| Valeant Pharmaceuticals Receives FDA Approval of Zelapar® for Patients with Parkinson's Disease -- Zelapar Significantly Reduces “Off” Time through Unique Delivery Mechanism --
COSTA MESA, Calif., June 15, 2006 - Valeant Pharmaceuticals International (NYSE: VRX) today announced that the U.S. Food and Drug Administration (FDA) 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. 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 chief executive officer, Timothy C. 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. Zelapar is the second therapy Valeant has brought to market to help in the treatment of Parkinson's disease, and we remain committed to the Parkinson's disease community and to providing therapies that fill the tremendous unmet medical need."
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.
"Patients with Parkinson's disease still experience many hours a day during which their treatment wears off," said Cheryl H. Waters, M.D., F.R.C.P. (C), Albert B. and Judith L. Glickman professor, Department of Neurology, Columbia University Medical Center. "The unique formulation of Zelapar allows the orally disintegrating tablet to dissolve within seconds. By delivering more active drug at a lower dose, Zelapar significantly reduces "off" time, giving valuable hours back to the patient."
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