Valeant Parkinson's Drug Gets FDA Approval
Posted on: Monday, 19 June 2006, 09:00 CDT
The FDA has approved Valeant Pharmaceuticals' Zelapar to be used in combination with standard drugs for the treatment of Parkinson's disease.
The drug has specifically been approved as a once-daily adjunct therapy for Parkinson's disease patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy.
The use of Zelapar as adjunctive therapy to levodopa/carbidopa has been shown to reduce "off" time, on average, by 2.2 hours per day. Levodopa/carbidopa is commonly used early in the treatment of Parkinson's disease, but as the disease progresses it becomes increasingly difficult to adequately control symptoms with this medication. Parkinson's disease patients may endure many hours of "off" time each day in which their symptoms return as a result of levodopa/carbidopa wearing off.
Zelapar, a monoamine oxidase-B (MAO-B) inhibitor, is the first Parkinson's disease treatment to use a novel oral delivery system called Zydis technology, which 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 CEO, 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."
Source: Datamonitor
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