FDA Approves Less-Restrictive Labeling for Tasmar
COSTA MESA, Calif., February 22, 2006 - Valeant Pharmaceuticals International today announced that the U.S. Food and Drug Administration (FDA) has approved less-restrictive labeling for Tasmar (tolcapone), the company's COMT (catechol-O-methyltransferase) inhibitor product for Parkinson's disease patients undergoing treatment with levodopa/carbidopa. The new labeling calls for less frequent laboratory monitoring for patients taking the drug, and allows patients to remain on Tasmar at higher ALT levels than previously required. The less-restrictive monitoring requirements may make physicians more comfortable prescribing Tasmar, potentially allowing more Parkinson's disease patients to benefit from the up to 3.2 hours reduction in daily "off" time Tasmar has been shown to provide.
"To date, more than 365,000 Tasmar prescriptions have been written for Parkinson's disease patients undergoing treatment with levodopa/carbidopa, while more than 1.5 million Americans suffer from this debilitating disease," said Timothy C. Tyson, Valeant's president and chief executive officer. "The new labeling for Tasmar will allow physicians to prescribe the drug, which has been proven to be safe and effective, to more Parkinson's disease patients."
The FDA approved less-restrictive labeling for Tasmar as a result of data analysis that demonstrated elevations in SGPT/ALT and SGOT/AST levels among patients being treated with Tasmar were rare. Valeant presented to the FDA more than 40,000 patient years of worldwide Tasmar IMS prescription data and an analysis was done of laboratory data in more than 3,400 Tasmar-treated patients participating in clinical trials. The newly approved labeling states that serum SGPT/ALT and SGOT/AST levels should be determined at baseline, as well as periodically (i.e., every two to four weeks) for the first six months of therapy, for patients where treatment with Tasmar has been deemed appropriate. In addition, periodic monitoring is recommended at intervals deemed clinically relevant after the first six months of therapy.
"Tasmar has long been a safe and effective treatment option for Parkinson's disease patients," said Dr. C. Warren Olanow, Professor of Neurology at the Mount Sinai School of Medicine in New York City, "Recent data suggests that hepatic dysfunction associated with Tasmar is rare and can be addressed with less restrictive monitoring. The new, less restrictive changes in Tasmar's labeling means that doctors can now feel more confident prescribing Tasmar to a broader patient population."
About Tasmar (tolcapone)
Tasmar is an adjunctive therapeutic agent used in combination with levodopa and DDCI for patients with severe Parkinson's disease who are not responding satisfactorily or are not appropriate candidates for other adjunctive therapies. Tasmar is classified as a COMT inhibitor.
Important Safety Information
USE OF TASMAR REQUIRES WRITTEN INFORMED CONSENT BY THE PATIENT (SEE PATIENT CONSENT SECTION IN THE COMPLETE PRESCRIBING INFORMATION).
Due the risk of potentially fatal, acute fulminant liver failure, TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's disease on levidopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies (see INDICATIONS and DOSAGE AND ADMINISTRATION sections). Due to the risk of liver injury and because TASMAR, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment, should be withdrawn from TASMAR. TASMAR therapy should not be initiated if the patient exhibits clinical evidence of liver disease or two SGPT/ALT or SGOT/AST values greater than the upper limit of normal. Patients with severe dyskinesia or dystonia should be treated with caution (see PRECAUTIONS: Rhabdomyolysis).
For further information, please see the BOXED WARNING and the complete prescribing information for TASMAR, which can be found at www.tasmar.com.
About Parkinson's Disease
An estimated 1.5 million Americans are afflicted with Parkinson's disease, with more than 60,000 news cases diagnosed each year - a number expected to increase as the baby boomer generation ages. Globally, there are an estimated four million people affected by Parkinson's disease. Parkinson's disease affects nearly equal numbers of men and women, with no obvious social, ethnic, economic or geographic boundaries. There presently is no cure for the disease, and the cause is unknown.
Source: Valeant Pharmaceuticals
Posted: February 2006