The company said the Food and Drug Administration has OK'd Zelapar orally disintegrating tablets as a once-daily adjunct therapy for Parkinson's disease patients being treated with levodopa/carbidopa and for whom this combination is losing effectiveness.
Parkinson's patients typically start off on the levodopa/carbidopa combination, but as their disease progresses, the drug cocktail becomes less effective and patients' "off" times -- or those time periods where the medicines wear off and their symptoms return -- become longer.
Zelapar has been shown to decrease these off times by an average of 2.2 hours per day, Valeant said.
The firm said Zelapar is the first therapy approved for Parkinson's to use a unique delivery system that allows the tablets to dissolve within seconds in the mouth and deliver more active drug at a lower dose.
"With more than 1.5 million Americans with Parkinson's disease, and 60,000 new cases diagnosed each year, having new treatment options available to help manage the symptoms associated with the disease are critical," said Valeant President and Chief Executive Officer Timothy Tyson. "The approval of Zelapar means that patients now have an additional alternative that can help them significantly reduce their daily 'off' time during waking hours," he said.
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