Valeant receives FDA approval of Zelapar for patients with Parkinson's disease

By Elaine Rigoli

Tampa, Fla., June 15 - Valeant Pharmaceuticals International said the Food and Drug Administration has approved Zelapar (selegiline HCl) orally disintegrating tablets, 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.

Valeant said Zelapar, a monoamine oxidase-B inhibitor, is the first Parkinson's disease treatment to use an 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.

Further, the company said 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.

The effectiveness of Zelapar as an adjunct to levodopa/carbidopa in the treatment of Parkinson's disease in patients who exhibit deterioration in the quality of their response to this therapy was established in a 12-week multi-center, double-blind, randomized, placebo-controlled, parallel-group study.

Located in Costa Mesa, Calif., Valeant is a global science-based pharmaceutical company.

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