Valeant Pharmaceuticals International received an approval from the US Food and Drug Administration (FDA) for less-restrictive labelling for Tasmar (tolcapone), the company's COMT (catechol-O-methyltransferase) inhibitor product for Parkinson's disease patients undergoing treatment with levodopa/carbidopa.

The new labelling 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, states the company release.

"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. The new labelling for Tasmar will allow physicians to prescribe the drug, which has been proven to be safe and effective, to more Parkinson's disease patients," said Timothy C. Tyson, Valeant's president and chief executive officer.

The FDA approved less-restrictive labelling 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 labelling 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.