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Comtan(R) Receives FDA Approval For Marketing - New Advance In The Management Of Parkinson's Disease -

October 20, 1999

"Comtan is an important new treatment in the management of Parkinson's Disease because it can help improve motor performance and significantly increase the amount of 'on' time in patients by prolonging the benefits of levodopa/carbidopa preparations, the mainstay therapy," said Lynn Kramer, M.D., Vice President, Nervous System, Clinical Research and Development, Novartis Pharmaceuticals Corporation. "On" time refers to periods of relatively good function, marked by patients' ability to perform common but important daily activities such as walking, speaking, writing and dressing. "Off" time is characterized by periods of immobility and a time when patients with Parkinson's are incapable of independent movement.

Optimizing Standard Parkinson's Disease Treatment Comtan belongs to a new therapeutic class called COMT inhibitors that block the COMT enzyme, and thus, reduce the breakdown of levodopa before it reaches the brain. The addition of a COMT inhibitor to the treatment regimen ensures efficient use of the prescribed levodopa/carbidopa, resulting in greater and more sustained availability of levodopa for brain entry and extending the positive effect of each levodopa dose. Consistent exposure to dopamine allows patients to function more independently and for longer periods of time between doses, with fewer of the burdensome symptoms of Parkinson's Disease.

"One of the challenges to treating Parkinson's Disease is that over time levodopa loses its ability to deliver a smooth response, thereby causing patients to experience fluctuations in motor response with increasing disability. By including a COMT inhibitor, you can markedly enhance the utility of levodopa and reduce motor fluctuations. This results in increased 'on' time and may be of significant benefit to patients who experience the early signs of levodopa 'wearing-off'," said C. Warren Olanow, Head of Neurology, Mount Sinai School of Medicine, New York. "Furthermore, because the medication is simultaneously administered with each levodopa dose, it is simpler to administer, and thus, may increase their compliance."

Clinical Trials Demonstrate Significant Patient Benefits In worldwide, multi-center trials involving nearly 700 patients, Comtan improved motor performance in patients with Parkinson's and significantly increased the amounts of "on" time patients had each day when compared to placebo. The two pivotal Phase III studies are known as SEESAW (Safety and Efficacy of Entacapone Study Assessing Wearing Off), conducted by the Parkinson Study Group (PSG) in North America and NOMECOMT (Nordic Multicenter Entacapone COMT Trials), conducted by the Nordic Study Group in Scandinavia. Both studies demonstrated that Comtan helped improve motor function in patients who showed deteriorating response to levodopa/carbidopa, particularly on important activities of daily living such as speaking, handwriting, walking and dressing.

In SEESAW, the Unified Parkinson's Disease Rating Scale (UPDRS) scores improved significantly in the Comtan treatment group vs. placebo (p<0.05). Comtan also increased "on" time significantly (p=.016). In NOMECOMT, "on" time based on home diaries of patients within the trial, increased significantly in the entacapone treatment group by 1.4 hours per day (p<0.001), compared to placebo. Both studies showed improved UPDRS scores, as well as a clinically significant reduction in "off" time (p<0.01).

A third study conducted in Germany and Austria further demonstrated the improvement in patients' motor function and activities of daily living that occurs when Comtan is added to the patients' levodopa/carbidopa therapy. This evidence supports the findings in the Nordic and North American studies.

"In essence, Comtan completes the standard regimen, making optimal use of levodopa/carbidopa combination and allowing patients to benefit from increased motor function and extended periods of improved daily activities," added Dr. Kramer. "This meaningful benefit allows patients to continue pursuing activities they enjoy which, in turn, may improve the quality of life they and their caregivers experience."

Researchers who administered Comtan in these worldwide clinical trials found that it has a favorable side effect profile and is generally well tolerated and does not require any specific safety monitoring. The most commonly reported side effects were dyskinesia, nausea, diarrhea, abdominal pain and urine discoloration. Dopaminergic side effects like dyskinesia often improved after adjustment of the levodopa dosage.

Overview on Treatment Challenges in Parkinson's Disease As Parkinson's Disease progresses, the benefits received from levodopa tend to shorten; a phenomenon commonly referred to as "wearing-off." Some of the common "wearing-off" symptoms that occur or re-emerge before the next dose of levodopa are poor coordination at meal times, shuffling while walking, problems getting in and out of a car, stiffness on rising out of a chair, difficulties buttoning a shirt, problems tying shoes and fatigue, among others. When "wearing-off" occurs, it is often necessary to increase the dose and/or frequency of levodopa administration or add a controlled release levodopa preparation in hope that enough levodopa may consistently reach the brain. While dosage manipulations may be effective, they can have limitations, which is why some physicians look for better ways to extend the benefits of levodopa therapy.

"A medication that allows for smoother, more consistent delivery of levodopa to the brain, and safely provides enhanced clinical benefit, is a major advance," added Dr. Olanow. "With the addition of Comtan to the armamentarium of anti-parkinsonian therapies, we have a very important new treatment in management of Parkinson's Disease."

Comtan and Novartis Under a licensing agreement with Orion Corporation of Finland, Comtan is marketed in the U.S. by Novartis Pharmaceuticals Corporation. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation, is an affiliate of Novartis AG, a world leader in Life Sciences with core businesses in Healthcare, Agribusiness and Consumer Health (Nutrition and Self-Medication). In 1998 sales for the Novartis group of companies were $21.8 billion, of which $12.0 billion were in Healthcare, $5.8 billion in Agribusiness and $4 billion in Consumer Health. The group annually invests more than $2.6 billion in research and development. Headquartered in Basel, Switzerland, the Novartis Group employs about 82,000 people and operates in over 140 countries around the world.

* Full prescribing information is available upon request.

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