Valeant sees restrictions on Tasmar labelling relaxed

Restrictions on the use of Parkinson’s drug Tasmar have been relaxed by the US Food and Drug Administration (FDA).

The new labelling for Tasmar, a catechol-O-methyltransferase (COMT) inhibitor manufactured by Valeant Pharmaceuticals, will allow patients who receive the drug to undergo less laboratory testing and have higher alanine transaminase (ALT) enzyme levels than previously required.

Valeant said the drug had been shown to give Parkinson’s patients up to 3.5 hours of “off” time and added that the new relaxed label will make it easier for doctors to prescribe the treatment.

“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 CEO Timothy C Tyson.

“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.”

The FDA decision was made following the presentation of patient data that showed that exaggerations in ALT and aspartate transaminase (AST) enzyme levels were rare amongst users. New labelling says that ALT and AST checks should be made regularly during the first half year of treatment.

On January 9th this year, Tasmar was reintroduced in the United Kingdom after a seven-year suspension from the market in the European Union (EU).

The drug was suspended from the EU market by the European Medicines Evaluation Agency (EMEA) in November 1998 due to the risks for neuroleptic syndrome and rare but potentially fatal acute hepatotoxicity.

The action followed three deaths from liver injury in elderly women whose liver function had not been assessed prior to initiation of therapy, and who had not been monitored during treatment as directed. In a fourth woman, symptoms of liver dysfunction resolved completely upon discontinuation of therapy.

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