ARCALYST(TM), First And Only FDA-approved Treatment For Cryopyrin-Associated Periodic Syndromes (CAPS), Now Available In The United States
March 28, 2008
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced ARCALYST™ (rilonacept) Injection for Subcutaneous Use is now available for prescription in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. Regeneron was granted marketing approval for ARCALYST by the U.S. Food and Drug Administration in February 2008, making it the only therapy approved for patients with CAPS, a group of rare, inherited, auto-inflammatory conditions characterized by life-long symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli. To avoid triggers that cause flares, patients often adopt a compromised lifestyle with limitations on everyday activities.
“Recognizing the painful, isolated lives experienced by patients with CAPS, we are pleased that we can offer these patients an FDA-approved therapy that helps control its debilitating symptoms,” said Leonard S. Schleifer, M.D., Ph.D., Regeneron’s president and chief executive officer.” Just as we were dedicated to developing a therapy for this condition with a large unmet medical need, we are also fully committed to assisting CAPS patients in gaining access to ARCALYST treatment. We have developed a comprehensive support program for CAPS patients and their physicians to help fulfill this goal.”
Regeneron has introduced the Regeneron ARC (ARCALYST Resource Center), which provides assistance to:
-help CAPS patients find appropriate medical care from trained healthcare providers
-prepare CAPS physicians to diagnose and appropriately treat these rare conditions
-aid CAPS patients in securing insurance authorization
-refer CAPS patients to company-sponsored and third-party financial assistance programs, when appropriate
ARCALYST is being distributed through two specialty pharmacies, which will directly mail patients a monthly shipment of ARCALYST and the supplies needed for self-injection. The pharmacies will also provide access to self-injection training and adherence counseling to patients who need those services.
More information about ARCALYST and the Regeneron ARC is available to patients and physicians through a toll-free number at 1-877-REGN777 (1-877-734-6777).
About Cryopyrin-Associated Periodic Syndromes (CAPS)
Recently, medical researchers have identified and described a group of rare, inherited, auto-inflammatory disorders, known as Cryopyrin-Associated Periodic Syndromes or CAPS. Three related conditions make up the broader disease known as CAPS: Familial Cold Auto-inflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), and Neonatal-Onset Multisystem Inflammatory Disease (NOMID). ARCALYST is not indicated for use in, and has not been studied in, patients with NOMID.
CAPS are characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli.
CAPS are generally caused by autosomal-dominant mutations (changes) in the NLRP-3 (previously known as CIAS1) gene and resultant alterations in the protein, cryopyrin, which it encodes. Cryopyrin, active in circulating, infection-fighting, white blood cells, controls the production of a protein called interleukin-1 (IL-1). As part of the body’s infection-fighting defense system, IL-1 circulates throughout the body and can trigger inflammatory reactions when it binds to inflammatory cells. Researchers have found that alterations in the cryopyrin protein lead to over-production of IL-1, resulting in an inflammatory response and the symptoms of CAPS. Most, but not all, patients with CAPS have the NLRP-3 gene mutation.
The incidence of CAPS has been reported to be approximately 1 in 1,000,000 people in the United States.
About ARCALYST™ (rilonacept)
ARCALYST is a targeted inhibitor of interleukin-1 (IL-1), the key driver of inflammation in Cryopyrin-Associated Periodic Syndromes (CAPS). In the pivotal clinical development program for ARCALYST, change in disease activity was measured using a composite symptom score composed of a daily evaluation of rash, feelings of fever/chills, joint pain, eye redness/pain, and fatigue. Patients treated with ARCALYST experienced an improvement in overall symptom scores as compared with patients treated with placebo. These improvements were noted within several days of initiation of ARCALYST therapy in most patients and were sustained over time with continued treatment with ARCALYST. The most commonly reported adverse reactions with ARCALYST were injection-site reaction and upper respiratory tract infection.
ARCALYST is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. IL-1 blockade may interfere with immune response to infections. Serious, life-threatening infections have been reported in patients taking ARCALYST. ARCALYST should be discontinued if a patient develops a serious infection. Taking ARCALYST with tumor necrosis factor inhibitors is not recommended because this may increase the risk of serious infections. Treatment with ARCALYST should not be initiated in patients with active or chronic infections. Patients should not receive a live vaccine while taking ARCALYST™ (rilonacept). It is recommended that patients receive all recommended vaccinations prior to initiation of treatment with ARCALYST. Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted. Hypersensitivity reactions associated with ARCALYST administration have been rare. Please see the full Prescribing Information for ARCALYST, available online at http://www.regeneron.com/ARCALYST-fpi.pdf
About Regeneron Pharmaceuticals, Inc.
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST™ (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. Additional information about Regeneron and recent news releases are available on Regeneron’s Web site at http://www.regeneron.com
Forward Looking Statement
This news release discusses historical information and includes forward-looking statements about Regeneron and its products, development programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of Regeneron’s drug candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize its product and drug candidates, competing drugs that are superior to Regeneron’s product and drug candidates, uncertainty of market acceptance of Regeneron’s product and drug candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement, including Regeneron’s agreements with the sanofi-aventis Group and Bayer HealthCare, to be canceled or to terminate without any product success, risks associated with third party intellectual property, and other material risks. A more complete description of these and other material risks can be found in Regeneron’s filings with the United States Securities and Exchange Commission (SEC), including its Form 10-K for the year ended December 31, 2007. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise unless required by law.
http://www.regeneron.com
Suspended Animation Using Sewer-Gas Is Rapid And Reversible
March 26, 2008
Low doses of the toxic gas responsible for the unpleasant odor of rotten eggs can safely and reversibly depress both metabolism and aspects of cardiovascular function in mice, producing a suspended-animation-like state. In the April 2008 issue of the journal Anesthesiology, Massachusetts General Hospital (MGH) reseachers report that effects seen in earlier studies of hydrogen sulfide do not depend on a reduction in body temperature and include a substantial decrease in heart rate without a drop in blood pressure.
“Hydrogen sulfide is the stinky gas that can kill workers who encounter it in sewers; but when adminstered to mice in small, controlled doses, within minutes it produces what appears to be totally reversible metabolic suppression,” says Warren Zapol, MD, chief of Anesthesia and Critical Care at MGH and senior author of the Anesthesiology study. “This is as close to instant suspended animation as you can get, and the preservation of cardiac contraction, blood pressure and organ perfusion is remarkable.”
Previous investigations into the effects of low-dose hydrogen sulfide showed that the gas could lower body temperature and metabolic rate and also improved survival of mice whose oxygen supply had been restricted. But since hypothermia itself cuts metabolic needs, it was unclear whether the reduced body temperature was responsible for the other observed effects. The current study was designed to investigate both that question and the effects of hydrogen sulfide inhalation on the cardiovascular system.
The researchers measured factors such as heart rate, blood pressure, body temperature, respiration and physical activity in normal mice exposed to low-dose (80 ppm) hydrogen sulfide for several hours. They analyzed cardiac function with electrocardiograms and echocardiography and measured blood gas levels. While some mice were studied at room temperature, others were kept in a warm environment - about 98o F - to prevent their body temperatures from dropping.
In all the mice, metabolic measurements such as consumption of oxygen and production of carbon dioxide dropped in as little as 10 minutes after they began inhaling hydrogen sulfide, remained low as long as the gas was administered, and returned to normal within 30 minutes of the resumption of a normal air supply. The animals’ heart rate dropped nearly 50 percent during hydrogen sulfide adminstration, but there was no significant change in blood pressure or the strength of the heart beat. While respiration rate also decreased, there were no changes in blood oxygen levels, suggesting that vital organs were not at risk of oxygen starvation.
The mice kept at room temperature had the same drop in body temperature seen in earlier studies, but those in the warm environment maintained normal body temperatures. The same metabolic and cardiovascular changes were seen in both groups, indicating that they did not depend on the reduced body temperature, and analyzing the timing of those changes showed that metabolic reduction actually began before body temperature dropped.
“Producing a reversible hypometabolic state could allow organ function to be preserved when oxygen supply is limited, such as after a traumatic injury,” says Gian Paolo Volpato, MD, MGH Anesthesiology research fellow and lead author of the study. “We don’t know yet if these results will be transferable to humans, so our next step will be to study the use of hydrogen sulfide in larger mammals.”
Zapol adds, “It could be that inhaled hydrogen sulfide will only be useful in small animals and we’ll need to use intravenous drugs that can deliver hydrogen sulfide to vital organs to prevent lung toxicity in larger animals.” Zapol is the Reginald Jenney Professor of Anaesthesia at Harvard Medical School.
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The study was supported by grants from the National Institutes of Health and Linde Gas Therapeutics. Additional co-authors of the Anesthesiology report are Robert Searles, Binglan Yu, PhD, Fumito Ichinose, MD, and Kenneth Bloch, MD, MGH Anesthesia; and Marielle Scherrer-Crosbie, MD, MGH Cardiology.
Massachusetts General Hospital (www.massgeneral.org), established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $500 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.
Source: Sue McGreevey
Massachusetts General Hospital
Cod Liver Oil Reduces Painkiller Use
March 26, 2008
“Two teaspoons of cod liver oil a day can cut the number of powerful painkillers needed to ease the pain of arthritis”, reports the Daily Mail. Patients who were given the supplements “were able to reduce their daily dose of anti-inflammatory drugs”, the newspaper says. These findings are important because the long-term use of anti-inflammatory drugs “can double the threat of heart attack and raise the risk of strokes and heart disease”, the Mail adds.The reports are based on a small study in people with rheumatoid arthritis that showed the potential benefits of cod liver oil capsules in reducing the use of non-steroidal anti-inflammatory drugs (NSAIDs). The picture is complicated because the people taking the capsules were also on other drugs for their rheumatoid arthritis, and the study did not aim to reduce the dosages of these other medications. Not all people with rheumatoid arthritis will be able to reduce their NSAID dosage with cod liver oil capsules, and some people will not be able to stick with the daily regimen of 10 capsules. Although cod liver oil supplements may be worth considering by some people with rheumatoid arthritis, patients should talk to their doctor before making any drastic changes in the medicines they take.
Where did the story come from?
Dr Bernat Galarraga and colleagues from the Ninewells Hospital and Medical School in Dundee; the Western General Hospital in Edinburgh, and the University of Dundee, carried out this research. The study was funded by Willem Van Dias and Seven Seas Ltd, who sell cod liver oil capsules and other food “supplements”. It was published in the peer-reviewed medical journal: Rheumatology.
What kind of scientific study was this?
This was a double-blind randomised controlled trial looking at whether taking high strength cod liver oil capsules could reduce the need for specific painkillers (NSAIDs) in people with rheumatoid arthritis. Cod liver oil contains the essential fatty acids DHA and EPA, which are thought to have anti-inflammatory effects.
The researchers enrolled 97 people aged 37 to 78 years old with rheumatoid arthritis (who had had the disease for an average of 13 years) from the rheumatology departments of two hospitals in Dundee and Edinburgh. To be included in the study, the person’s disease and medication had to have been stable for the past three months, and they had to have been taking regular NSAID medication. People with unstable disease that required changes in medication, those taking high doses of steroids, those with other severe diseases or those already taking supplements containing essential fatty acids were excluded.
Eligible participants were assigned at random to nine months treatment of either daily capsules containing a mixture of cod liver oil and fish oil (Seven Seas Marine Oil 1 capsules), containing 10g of oil in total, or identical air filled capsules (a placebo). At three and nine months, blood samples were taken to measure the levels of the essential fatty acid EPA (contained in cod liver oil) to see if participants had been taking their capsules.
Participants were also asked to record their daily NSAID use. After 12 weeks, participants were asked to gradually reduce their use of NSAIDs, and then stop using them if possible. The researchers calculated how much NSAID medication participants were using on average daily, how severely they were affected by their disease, and how active their disease was at the start of the study, as well as at four, 12, 24 and 36 weeks. The researchers then looked at how these levels changed over the study in the cod liver oil and placebo groups. They were primarily interested in comparing what proportion of people in each group had been able to reduce their daily NSAID use by more than 30% over the course of the study. Any participants who dropped out of the study were included in analyses, and assumed to have not reduced their NSAID usage by more than 30%.
What were the results of the study?
Only 60% of participants completed the full nine-month study period. More people in the cod liver oil group (39%) were able to reduce their NSAID intake by more than 30% compared with the placebo group (10%). This reduction was still significant following exclusion of the seven people (four in the cod liver oil group and three in the placebo group) whose use of other medications (such as steroids) increased during the study.
In general, there was no difference between the groups in the severity or activity of the disease on any of the measures used, except for a small but significant reduction in self-reported pain in the cod liver oil group compared with the placebo group. There was no difference between the groups in the type or number of side effects experienced, which were mostly mild.
What interpretations did the researchers draw from these results?
The researchers concluded that cod liver oil capsules could be used by people with rheumatoid arthritis to cut their NSAID intake.
What does the NHS Knowledge Service make of this study?
This well-designed study provides some evidence that people with stable rheumatoid arthritis may be able to reduce their intake of NSAIDs by taking cod liver oil supplements. There are some points to note about the study:
-All participants in this study were taking NSAIDs, but it is not possible to say how much they were taking as the average doses at the start of the study were not given, and the results are given as percentage reductions in dose only. Also, there is not much information provided on the type of NSAID that were being used. There are a large number of NSAID drugs, and anti-inflammatory properties vary considerably from those in over-the-counter NSAIDs such as ibuprofen, to more potent medications such as indometacin.
-Although this was a double-blind study, participants may have been able to guess what they were taking because of the fishy aftertaste of the cod liver oil capsules, and the difference between air-filled and oil-filled capsules. This knowledge may have affected people’s willingness to reduce their NSAID dosage.
-The authors of the study note that the high level of withdrawals is a limitation to their study, and suggest that this was in part linked to people’s unwillingness to take 10 extra capsules a day and to digestive system problems when taking capsules.
-Most people on this study were also taking disease-modifying anti-rheumatic drugs (DMARDS) for their rheumatoid arthritis, which, rather than providing pain and inflammation relief as NSAIDs do, are drugs used to actually “treat” the condition. They have an effect upon the body’s immune response, and can suppress the disease process and alter its progression. The study did not attempt to see whether cod liver oil use affected the use of these drugs.
-All people in this study had stable rheumatoid arthritis. These results may not be applicable to those with severe disease, and cannot be generalised to those with other arthritic conditions.
People with rheumatoid arthritis should consult their doctor before making any drastic changes in their medication.
Links to the headlines
Cod liver oil cuts arthritis pain without the side-effects of painkillers. Daily Mail, March 25 2008
Cod liver oil ‘helps ease pain’ of arthritis. The Daily Telegraph, March 25 2008
Links to the science
Cod liver oil (n-3 fatty acids) as an non-steroidal anti-inflammatory drug sparing agent in rheumatoid arthritis.
Galarraga B, Ho M, Youssef HM, et al.
Rheumatology 2008; Mar 24
This news comes from NHS Choices
ASA Commemorates Doctors Day 2008
March 25, 2008
The American Society of Anesthesiologists will join communities across the United States to celebrate Doctors Day on March 30.
While physicians in all specialties and in primary care are honored, Doctors Day was first observed in recognition of the efforts of one physician whose endeavors relate specifically to the specialty of anesthesiology.
Doctors Day marks the date that Crawford W. Long, M.D., of Jefferson, GA, administered the first ether anesthetic for surgery on March 30, 1842. On that day, Dr. Long administered ether anesthesia to a patient and then operated to remove a tumor from the man’s neck. Later, the patient would swear that he felt nothing during the surgery and wasn’t aware the surgery was over until he awoke
Doctors Day celebrates Dr. Long’s historic achievement and the continued efforts of physicians to alleviate human suffering and improve patient safety. This year’s celebration marks the 50th anniversary of the national recognition of Doctors Day.
“Without the efforts of Dr. Long, modern medicine and surgery as we know it would not exist,” said ASA president Jeffrey L. Apfelbaum, M.D.
“Anesthesiologists have continued to make medical and research advances, creating a specialty comprised of highly trained physicians who serve as patient advocates throughout surgery from preanesthesia evaluation to recovery.
Anesthesiologists often serve as the primary physician in pain medicine and critical care medicine and as lead consultants in a multitude of subspecialty areas including obstetrics, neurosurgery, interventional medicine, interventional pediatrics, and cardiothoracic surgery.”
Focused on patient safety and innovative care, ASA was the first medical specialty society to develop and adopt standards of care for its members as early as 1986. Today, more than 30 standards, guidelines and statements and more than 10 evidence-based practice parameters have been developed by ASA to address monitoring standards during surgery, as well as anesthesiologist’s direct involvement in patient care and pain management before, during and after surgery.
On Doctors Day ASA encourages its members educate to colleagues, patients and the public about Doctors Day and the contributions of anesthesiologists to the safety and well-being of patients.
Founded in 1905, the American Society of Anesthesiologists is an educational, research and scientific association with 43,000 members organized to raise and maintain the standards of the medical practice of anesthesiology and improve the care of the patient.
Visit the ASA Web site at http://www.asahq.org.
American Society of Anesthesiologists (ASA)
520 N. Northwest Hwy.
Park Ridge, IL 60068-2573
United States
http://www.ASAhq.org
Long-Term Data For 884 Patients Show Vertebroplasty For Osteoporotic Spinal Fractures Provides Dramatic Pain Relief, Greatly Decreases Disability
March 19, 2008
The results of a five-year follow-up study of 884 osteoporosis patients bolster the use of vertebroplasty — an interventional radiology treatment for vertebral compression fractures — finding that the procedure provides dramatic pain relief and sustained benefit, announced researchers at the Society of Interventional Radiology’s 33rd Annual Scientific Meeting. Vertebroplasty, the injection of medical-grade bone cement into a fractured vertebra, shores up the fracture similar to an internal cast and provides pain relief. It is indicated for painful vertebral compression fractures that fail to respond to conventional medical therapy, such as minimal or no pain relief with analgesics or narcotic doses that are intolerable. The average pre-treatment pain score on the 11-point Visual Analog Scale was 7.9 +/- 1.5, and it dropped significantly to an average of 1.3 +/- 1.8 after the vertebroplasty treatment.
One’s ability to manage everyday life — such as washing, dressing or standing–was measured by the commonly used Oswestry Disability Questionnaire (ODQ), which was completed by patients before — and again one month after–vertebroplasty. The ODQ scores changed from an average of 69.3 percent +/- 13.5 to 18.8 percent +/- 6.9, showing a highly significant improvement in mobility.
“These data provide good news for physicians and osteoporosis patients. Many osteoporosis patients with compression fractures are in terrible pain and have a greatly diminished ability to perform basic daily activities, such as dressing themselves,” said Giovanni C. Anselmetti, M.D., interventional radiologist at the Institute for Cancer Research and Treatment in Turin, Italy.
Vertebroplasty can greatly improve one’s quality of life; however, the treatment is generally reserved for patients who have failed conventional medical management.
“Osteoporosis patients who have persistent spinal pain lasting more than three months should consult an interventional radiologist, and those who require constant narcotic pain relief should seek help immediately,” noted Anselmetti. The treatment was completed in all patients without major complications and with good clinical results. The data add to the body of evidence in the United States for the minimally invasive treatment’s safety, effectiveness and low-complication rate. The treatment is widely available in the United States at all major institutions and many smaller institutions and is generally covered by health insurance.
The study also showed that vertebroplasty does not increase the risk of fracture in nearby vertebra. “Vertebroplasty is already known to be a safe and effective treatment for osteoporotic vertebral fractures. Osteoporosis patients remain susceptible to new fractures, which often occur in the contiguous vertebra to an existing fracture. Our large-scale study shows that vertebroplasty does not increase the risk of fracture in the level contiguous to previously treated vertebra and that these new fractures occur at the same rate as they would in osteoporosis patients who did not have vertebroplasty,” added Anselmetti.
Abstract 182, “Percutaneous Vertebroplasty in the Osteoporotic Patients: Five Years Prospective Follow-up in 884 Consecutive Patients,” can be found at http://www.SIRmeeting.org.
About Vertebroplasty
Vertebroplasty was first performed in France in 1984 to treat compression fractures caused by bone cancer or bone metastasis and later to treat compression fractures caused by osteoporosis. Percutaneous vertebroplasty was introduced in the United States in 1994 and has become widely available since 1997 as a treatment for pain associated with compression fractures due to osteoporosis. The procedure has been shown to provide continued pain relief for osteoporotic compression fractures.
Vertebroplasty is indicated for painful vertebral compression fractures that fail to respond to conventional medical therapy, such as minimal or no pain relief with analgesics or narcotic doses that are intolerable. Vertebroplasty is an outpatient procedure performed under X-ray-imaging guidance and conscious sedation. The interventional radiologist inserts a needle through a nick in the skin in the back, directing it under fluoroscopy (continuous, moving X-ray imaging) into the fractured vertebra. The physician then injects the medical-grade bone cement into the vertebra. The cement hardens within about 15 minutes and stabilizes the fracture.
About Osteoporosis
Osteoporosis is characterized by low bone mass and structural deterioration of the bone, resulting in an increased susceptibility to fractures. A major public health issue, osteoporosis affects 10 million Americans and is responsible for 1.5 million vertebral fractures each year, according to National Institutes of Health estimates. Multiple vertebral fractures can result in chronic pain and disability, loss of independence, stooped posture and compression of the lungs and stomach. Nearly all vertebral fractures in otherwise healthy people are due to osteoporosis and can occur from a minor impact, such as a bump or a fall, in those who suffer from this bone-weakening disease.
About the Society of Interventional Radiology
Interventional radiologists are physicians who specialize in minimally invasive, targeted treatments. They offer the most in-depth knowledge of the least invasive treatments available coupled with diagnostic and clinical experience across all specialties. They use X-ray, MRI and other imaging to advance a catheter in the body, usually in an artery, to treat at the source of the disease internally. As the inventors of angioplasty and the catheter-delivered stent, which were first used in the legs to treat peripheral arterial disease, interventional radiologists pioneered minimally invasive modern medicine.
Today many conditions that once required surgery can be treated less invasively by interventional radiologists. Interventional radiology treatments offer less risk, less pain and less recovery time compared to open surgery. Visit http://www.SIRweb.org.
Society of Interventional Radiology
http://www.sirweb.org
ProEthic Pharmaceuticals Announces Launch Of Ibudone For Acute Pain
March 17, 2008
ProEthic Pharmaceuticals, Inc. announced the launch of Ibudone™ (hydrocodone bitartrate and ibuprofen tablets), a new prescription fixed combination of hydrocodone and ibuprofen for the short-term (generally less than 10 days) management of acute pain.
Ibudone provides the highest hydrocodone/ibuprofen dosage available - 10 mg of hydrocodone/ 200 mg of ibuprofen - in each tablet. Peak plasma levels are achieved in less than two hours. Ibudone is also available with 5 mg hydrocodone/ 200 mg of ibuprofen.
Carl Whatley, Chairman and CEO of ProEthic Pharmaceuticals, stated, “By combining 10 mg of hydrocodone with the gold standard NSAID, ibuprofen, Ibudone offers a powerful new option for relieving acute pain. It is important to note that Ibudone does not have the risk of acetaminophen liver toxicity, a leading cause of acute liver failure in the United States. In addition, Ibudone also offers physicians Schedule III prescribing convenience, a key issue with today’s busy practices.”
ProEthic acquired the exclusive marketing, sales and distribution rights to Ibudone from Vintage Pharmaceuticals (Huntsville, Alabama). To learn more about Ibudone, visit http://www.ibudone.com.
Important Information about Ibudone
Ibudone (hydrocodone bitartrate and ibuprofen tablets) is indicated for the short-term (generally less than 10 days) management of acute pain. Ibudone tablets are not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis. Ibudone should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). Serious gastrointestinal toxicity, such as inflammation, bleeding, ulceration and perforation of the stomach, small intestine, or large intestine, with or without warning symptoms, can occur in patients taking NSAIDs. NSAIDs have been associated with an increase in cardiovascular adverse events. The most commonly reported side effects with Ibudone include headache, nausea, dizziness, dyspepsia, somnolence, and constipation. Hydrocodone may impair mental and/or physical abilities when ingested with alcohol and other CNS depressants. Ibudone tablets should be used with caution in elderly or debilitated patients, and in those patients with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy, or urethral stricture.
Please see full Prescribing Information for more on Warnings, Precautions and additional Adverse Reactions that may occur.
About ProEthic Pharmaceuticals, Inc.
ProEthic is an emerging specialty pharmaceutical company enhancing treatment strategies initially in the areas of pain and migraine. Founded in 2001, the privately held company focuses its efforts on the acquisition, development, licensing, and marketing of pharmaceutical products.
ProEthic Pharmaceuticals
Aspect Medical Systems Provides Commentary And Information On New England Journal Of Medicine Study On Anesthesia Awareness And The Bispectral Index
March 14, 2008
Aspect Medical Systems (NASDAQ: ASPM), the global market leader in brain monitoring technology, commented on the results from a prospective study of the potential of the Bispectral Index™ (BIS™) to reduce the risk of anesthesia awareness. The study, published in the March 13 issue of the New England Journal of Medicine (NEJM), evaluated a patient population considered to be at high risk for anesthesia awareness, or inadvertent waking during surgery. Researchers compared BIS-guided anesthesia care with a protocol based on end-tidal anesthetic gas (ETAG) guided care and found a similar occurrence of awareness in the two groups. The authors concluded that no benefit of BIS monitoring was demonstrated. The results of the BIS-guided care group in the study were consistent with findings from the BIS-guided care group from the B-Aware study published in The Lancet in May 2004. The low incidence measured in the NEJM study represents an 80 percent reduction from the expected rate of awareness in these patients as documented in numerous studies.
“We are pleased that BIS-guided care in the NEJM study again confirms the ability of BIS monitoring to help clinicians achieve a low incidence of awareness in high-risk patient populations,” said Scott Kelley, M.D., anesthesiologist and vice president and medical director of Aspect Medical Systems. “Nonetheless, the authors of the NEJM study did not feel that their results support the routine use of BIS monitoring, however, we believe that clinicians need to consider and balance several factors as they interpret the study results.”
The most notable difference between the earlier B-Aware study and the NEJM study is the composition of the control groups. While the B-Aware trial investigators compared BIS-guided care with routine standard clinical practice, the authors of the NEJM study compared BIS-guided care with a protocol-based approach to anesthetic administration. In addition, the NEJM study does not include data regarding recovery end-points.
“The ETAG-guided protocol used in the NEJM study instructed the anesthesia professionals to use a certain amount of inhaled anesthetics and audible alarms set at the minimum level. This is not how anesthesia professionals routinely practice,” said Dr. Kelley. “We would expect that a protocol which provides significant amounts of volatile anesthesia would produce a low incidence of awareness in these patients.”
In practice, anesthesia professionals use clinical judgment, monitoring methods and preferences to select and dose a variety of anesthetic mediations to ensure that their patients are unconscious and free of pain during surgical procedures. A growing number of anesthesia clinicians also use brain monitoring information to help adjust the amount of anesthetic medication during surgery to personalize anesthetic care based on each patient’s unique responses.
“We believe that a protocol-based approach providing a certain amount of anesthetic to every patient would reduce the control and flexibility that anesthesia professionals depend upon to provide the best care,” said Dr. Kelley. “Anesthesia professionals are responsible for a quick recovery and mitigating post-operative pain as well as managing anesthesia care during surgery. An individualized approach to patient care helps optimize these post-operative outcomes.”
The NEJM study adds to the large body of evidence investigating the BIS monitor. A rigorous evidence-based review conducted by the Cochrane Collaboration demonstrates the broad clinical benefits of BIS monitoring. The Cochrane review analyzed 20 randomized controlled trials in which BIS-guided care was compared with standard practice and documented the positive impact of BIS monitoring in reducing anesthetic drug consumption, improving recovery and helping clinicians reduce the risk of awareness. In another meta-analysis of 12 studies, the author estimated that the reduction in drug use and improved recovery reduced the net cost of BIS monitoring to approximately $5.50 per case. “When considering the overall costs for a surgical procedure, this small additional cost to utilize BIS monitoring delivers significant value when considering the safety impact for reducing awareness as well as the choice, flexibility, and information it provides to the anesthesia professional delivering high quality patient care,” said Dr. Kelley.
More information about the NEJM trial, including a more detailed comparison with the B-Aware trial can be found at Aspect’s Web site at http://www.aspectmedical.com.
Aspect includes in this press release links to its Web site. Aspect cautions you that the information on its Web site is not incorporated by reference into this press release and should not be considered to be a part of this press release.
About Aspect Medical Systems, Inc.
Aspect Medical Systems, Inc. (NASDAQ: ASPM) is a global market leader in brain monitoring technology. To date, the Company’s Bispectral Index (BIS) technology has been used to assess approximately 25 million patients and has been the subject of more than 3,100 published articles and abstracts. BIS technology is installed in approximately 80 percent of hospitals listed in the July 2007 U.S. News and World Report ranking of America’s Best Hospitals and in approximately 60 percent of all U.S. operating rooms. In the last twelve months BIS technology was used in approximately 17 percent of all U.S. surgical procedures requiring general anesthesia or deep sedation. BIS technology is available in more than 160 countries. Aspect Medical Systems has OEM agreements with eight leading manufacturers of patient monitoring systems. For more information, please visit the Aspect Medical Systems Web site http://www.aspectmedical.com.
Safe Harbor Statement
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and may involve risks and uncertainties, including statements about the potential benefits of the Company’s brain monitoring technologies in helping anesthesia providers deliver anesthesia and in reducing the incidence of awareness and statements regarding the use and adoption of BIS monitoring technologies. There are a number of important factors that could cause actual results to differ materially from those indicated by these forward-looking statements. For example, future clinical trials could demonstrate different and/or unfavorable results regarding the potential benefits of the Company’s brain monitoring product. The Company may also not be able to achieve widespread market acceptance of its BIS monitoring technology, or to compete with new products or alternative techniques that may be developed by others, including third-party anesthesia monitoring products approved by the FDA. The Company also faces competitive and regulatory risks relating to its ability to successfully develop and introduce enhancements and new products including the BIS VISTA monitor and products based upon its neuroscience technology. Cases of awareness with recall during monitoring with the BIS system and significant product liability claims are among the factors that could limit market acceptance. There are other factors that could cause the Company’s actual results to vary from its forward-looking statements, including without limitation those factors described under the heading “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 29, 2007, which is on file with the SEC.
In addition, the statements in this press release represent the Company’s expectations and beliefs as of the date of this press release. The Company anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s expectations or beliefs as of any date subsequent to the date of this press release.
Aspect, Bispectral Index and BIS are registered trademarks of Aspect Medical Systems, Inc. All other trademarks, service marks and company names are the property of their respective owners.
Aspect Medical Systems
HealthSonix To Conduct Clinical Trials With ZingiberRx For Complex Regional Pain Syndrome (CRPS)
March 14, 2008
HealthSonix, Inc. (OTC:HSXI)(FWB:H7S) announced that it has strong evidence that ZingiberRx Joint and Muscle Cream with ginger oil can provide pain relief for people with Complex Regional Pain Syndrome (CRPS), also referred to as Reflex Sympathetic Dystrophy (RSD).
The main symptom of CRPS is intense chronic pain, often described as ‘burning’ pain. Additional signs and symptoms include localized swelling; changes in skin temperature and color; joint stiffness; muscle spasms, weakness and loss (atrophy); and decreased range of motion.
“We have been testing ZingiberRx with a CRPS group and the on-going positive feedback we get from the participants has led to the decision to conduct a formal scientific study for this condition,” said Dieter D. Doederlein, Vice President Corporate Development for HealthSonix.
“Members of our St Catharines CRPS support group had excellent outcomes from the ZingiberRx samples you provided. You definitely should consider a clinical trial,” said Helen Small, President of PARC, a national support group that is Promoting Awareness of RSD and CRPS in Canada.
“According to the Mayo Clinic, many cases of complex regional pain syndrome occur after a forceful trauma to an arm or a leg, as a result of motor vehicle accidents, shrapnel blasts and other traumas - such as surgery, heart attacks, infections, fractures and sprained ankles. This could open up a whole new market for ZingiberRx,” added Doederlein.
HealthSonix, Inc. (OTC: HSXI)(FWB: H7S) is a publicly traded research oriented medical technology company that develops and markets medical devices and healthcare products for institutional and consumer use. The company’s patent pending medical devices deliver sound pressure waves to the human body for relief of pain and other musculoskeletal conditions. The focus is on arthritis, athletic injuries and conditions where acute or chronic pain is the cardinal symptom.
Note: A number of statements contained in this news release are forward-looking statements, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve a number of risks and uncertainties, including the timely development and market acceptance of products and technologies, competitive market conditions, successful integration of acquisitions, the ability to secure additional sources of financing, the ability to reduce operating expenses and other factors not set forth herein. The actual results that the Company may achieve may differ materially from any forward-looking statements due to such risks and uncertainties.
http://www.HealthSonix.com
Anesthesia Awareness Monitor No Better Than Older Methods, Study
March 14, 2008
A new study by researchers in the US suggests that a new brain monitoring device that is widely used to check that surgery patients form no memories of their operation was no more effective at lowering the risk of “anesthesia awareness” than older methods. However, the researchers said that the results need to be confirmed with larger studies.
The study was conducted by principal investigator Dr Michael S Avidan, associate professor of anesthesiology and surgery at Washington University School of Medicine in St. Louis, and colleagues, and is published in the March 13 issue of the New England Journal of Medicine (NEJM).
Anesthesia awareness is extremely rare, and occurs in one or two surgical patients per thousand, said Avidan, “but because of the huge number of operations performed annually, the total number of people with awareness during anesthesia is significant,” he explained.
Anesthesia awareness suggests that patients form memories of the operation while they are under anesthesia. The condition is sometimes very distressing and can lead to long term anxiety and in some cases, post traumatic stress disorder.
Avidan and colleagues enrolled nearly 2,000 patients undergoing surgery at Barnes-Jewish Hospital in St. Louis. Half of the patients were monitored using a device that measures the patient’s bispectral index (BIS) using brain wave data taken by electroencephalogram. A person’s BIS is 100 when they are fully awake, and zero indicates no brain wave activity. Recommended practice is to keep BIS between 40 and 60 to stop anesthesia awareness during surgery.
The other patients were managed during surgery using an older method, called end-tidal anesthetic gas (ETAG), that measures the amount of anesthetic gas in the air exhaled by the patient. With ETAG, the anesthesiologist can see when the amount of exhaled anesthetic gas goes below a certain threshold, and can then decide whether to increase the level of anesthetic to keep the patient unconscious and unaware.
Avidan and colleagues also took BIS readings of the ETAG monitored patients.
This study was carried out because another one done four years ago suggested that using a BIS monitor could reduce anesthesia awareness risk, but one of Avidan’s co-investigators, Dr Alex S Evers, was not happy about the design of that study:
“The first study was like having a control group that got no treatment,” said Evers, who is the Henry E. Mallinckrodt Professor and head of the Department of Anesthesiology.
“We thought it made more sense to compare bispectral index to ETAG monitoring to see if we could detect any differences in the incidence of awareness between the two groups,” he explained.
The results showed that two patients in each group had formed memories of their surgical experience, which is 0.2 per cent of the overall number.
The investigators looked at the BIS readings of the ETAG group patients who had formed memories of their operation and found that those patients had been maintained within the recommended range that is supposed to prevent anesthesia awareness.
Avidan explained that:
“Part of the risk of awareness involves the surgical procedure and individual patients.”
“Bigger operations are more likely to produce awareness, so a person having open heart surgery will be at greater risk than one having cartilage removed from a knee,” he said.
He also explained that “patients who are sicker at the time of surgery, and those who take certain drugs or drink alcohol are more likely to have awareness.”
One drawback of this study is that 2,000 patients is not a large enough group to see if there are small differences in the BIS and ETAG methods. Avidan and colleagues plan to continue the study with larger groups.
Even patients with an elevated risk of anesthesia awareness will only experience it about 1 per cent of the time, said the researchers. And for those without a higher risk, the rate of experience is likely to be only one or two in 1,000. So to test the difference between the two methods more sensitively, it is better to use larger groups, they said.
Another potential problem that could be found about this study is that the algorithms in the BIS monitor were developed using intravenous anesthesia, whereas this study compared the methods using only anesthetic gases. But the researchers argued this was still a sensible thing to do because the majority of operations are done with anesthetic gases and not intravenous anasthetics, and thus they have produced a more realistic comparison of the methods.
The researchers concluded there was essentially no difference between the two methods:
“We were able to achieve a very low incidence of anesthesia awareness with both protocols,” said Avidan.
“But neither was able to eliminate the problem completely, and we worry that use of the bispectral index could give anesthesiologists a false sense of security that if they keep the measurement between 40 and 60, they’ll prevent anesthesia awareness. This study has demonstrated that’s not entirely true.”
Avidan said while these findings suggest current widespread use of BIS may not be warranted, larger studies need to confirm these results.
“Anesthesia Awareness and the Bispectral Index.”
Avidan, Michael S., Zhang, Lini, Burnside, Beth A., Finkel, Kevin J., Searleman, Adam C., Selvidge, Jacqueline A., Saager, Leif, Turner, Michelle S., Rao, Srikar, Bottros, Michael, Hantler, Charles, Jacobsohn, Eric, Evers, Alex S.
N Engl J Med 2008 358: 1097-1108
Volume 358, pages 1097-1108, March 13, 2008, Number 11
Click here for Abstract.
Sources: Washington University School of Medicine press release.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Innocoll Announces Dosing Of First Patient In A Second US Phase 2 Clinical Trial To Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT
March 14, 2008
Innocoll, Inc., a privately-held biopharmaceutical company, announced that the second of a series of planned phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the management of post-operative pain, has commenced dosing.
Innocoll’s BUPIVACAINE SURGICAL IMPLANT is a biodegradable and fully bioresorbable matrix of purified fibrillar collagen impregnated with the local anesthetic, bupivacaine, which has been specifically developed and formulated using Innocoll’s proprietary CollaRx sponge technology. It is under development in the US and Europe for the management of post-operative pain following moderate/major abdominal, gynecological, abdominal, thoracic, and orthopedic surgeries.
Post-operative pain is typically controlled with narcotic analgesics such as morphine, but systemic administration of these drugs can result in unfavorable side effects including suppression of breathing, sedation, nausea and vomiting, and can also affect patient recovery. Innocoll’s BUPIVACAINE SURGICAL IMPLANT is intended to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following surgery. The collagen matrix naturally biodegrades over a few days and the bupivacaine is released to provide local analgesia for up to 96 hours post- operatively. A key feature of Innocoll’s product is the ability to implant it directly into the surgical cavity and at different layers within the wound, such as across the peritoneum incision and directly below the skin incision, which enables localized treatment of both the incisional and deep, visceral pain components normally associated with moderate and major surgery. The bioresorbable nature of the collagen matrix also offers significant clinical benefits and convenience advantages over ambulatory infusion pumps often used to provide continuous, long-term analgesia at the site of a surgical wound.
Innocoll has already completed a phase 2 clinical trial in patients undergoing hysterectomy surgery in the absence of gynecological cancers at Wexham Park Hospital, Slough, UK. The results of this trial were particularly encouraging, showing evidence of sustained, post-operative analgesia for approximately 96 hours as measured by VAS (visual analogue scale) scores and reduced dependence on systemic morphine administered by PCA (patient- controlled analgesia). This extended action was achieved despite a low total bupivacaine dose (150mg as the hydrochloride salt), which is well below the allowable daily dose and equivalent to that used by some practitioners for a once-off wound infiltration with bupivacaine solution prior to wound closure
For the planned series of phase 2 multi-centered, controlled clinical trials to be performed in the US, Innocoll has appointed Premier Research Group, a recognized industry leader in clinical research for acute and chronic pain, to co-ordinate up to five trials in a variety of soft and hard tissue procedures; including hysterectomy, herniorrhaphy, open gastrointestinal surgery and orthopedic surgery. The first of these trials in patients undergoing abdominal hysterectomy commenced dosing in December 2007. This second trial will compare the analgesic effect of BUPIVACAINE SURGICAL IMPLANT versus a placebo implant in patients undergoing open mesh herniorrhaphy at five different US sites.
In addition to hysterectomy and inguinal hernia repair, other surgeries where the product could potentially be used routinely include caesarean section, mastectomy, open gastrointestinal surgery, cholecystectomy, open heart surgery, vascular surgery, and various orthopedic surgeries such as hip and knee replacement, bunionectomy, open fracture repair and certain bone graft procedures. Detailed market research performed independently by L.E.K. Consulting has predicted peak US sales of BUPIVACAINE SURGICAL IMPLANT nearing $310 million.
Dr. Michael Myers, Innocoll’s President and CEO commented, “The dosing of this second phase 2 trial with our Bupivacaine Implant for the management of post-operative pain follows closely behind other phase 2 and phase 3 trials recently initiated with our topically-applied Gentamicin-Collagen sponge for the treatment of infected diabetic foot ulcers and our Gentamicin Surgical Implant for the prevention of surgical site infection. We also have a number of other phase 2 trials that are expected to commence in the near future, confirming our strong commitment to the development of our late stage product portfolio.”
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. It develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R) and Liquicoll(R). Innocoll ’s lead product, Gentamicin Surgical Implant for the treatment and prevention of surgical site infections, is approved for sale in 49 countries in Europe, Latin America, Middle East, Africa and Asia and is marketed under the following trade names; COLLATAMP(R) G, COLLATAMP(R) EG, SULMYCIN(R) IMPLANT, GARAMYCIN(R) SCHWAMM, DURACOL(R), DURACOLL(R), GENTACOL(R), GENTACOLL(R), GARACOL(R), GARACOLL(R), and CRONOCOL(R). In 2007, Innocoll acquired the worldwide marketing rights for this product from Essex Chemis AG, an affiliated company of Schering-Plough Corporation (NYSE: SGP) and in August 2007 sold its marketing rights, with the exception of the US, to EUSA Pharma. Gentamicin Surgical Implant is currently in phase 3 development in the US for the prevention of surgical site infections. Other late stage pharmaceutical products in Innocoll’s development pipeline include CollaRx Gentamicin Topical for the treatment and prevention of infected diabetic foot ulcers and CollaRx Bupivacaine Implant for the management of post-operative pain, both of which are currently in Phase 2 development. For more information, please visit http://www.innocollinc.com.
Innocoll, Inc.
http://www.innocollinc.com
