COSTA MESA, C.A. -- July 18, 2006 -- Valeant Pharmaceuticals International today announced the U.S. launch of Zelapar(R) (selegiline HCl) Orally Disintegrating Tablets. Zelapar is the first Parkinson's disease treatment to use a novel oral delivery system called Zydis(R) Technology, which allows the tablets to dissolve within seconds in the mouth and deliver more active drug at a lower dose. Zelapar will be available in pharmacies nationwide by July 19, 2006.
"We're excited to launch Zelapar in the U.S. market and provide a safe and effective alternative treatment option to healthcare professionals and their patients. Zelapar has been shown to reduce daily 'off' time by 2.2 hours on average, providing an important benefit for patients living with the disease," said Valeant president and chief executive officer, Timothy C. Tyson. "The availability of Zelapar is a significant milestone for Valeant and underscores our ongoing commitment to the Parkinson's disease community. We will continue to work with the community throughout the life of this product and do all we can to improve the lives of those who suffer from this debilitating disease."
Zelapar is a selective monoamine oxidase inhibitor (MAO-B), which was approved by the U.S. Food and Drug Administration (FDA) on June 14, 2006 as a once-daily adjunct therapy for Parkinson's disease patients being treated with levodopa/carbidopa. The Zydis formulation allows Zelapar to significantly bypass the gut and is primarily absorbed into plasma through the oral mucosa, thereby potentially enhancing the therapeutic effect and reducing side effects.
About Parkinson's Disease
Parkinson's disease is a chronic, progressive disorder of the central nervous system that belongs to a group of conditions called motor system disorders. The symptoms of Parkinson's disease appear when approximately 80 percent of neurons in an area of the brain called the substantia nigra become impaired.
In the United States, 1.5 million Americans currently have Parkinson's disease. It is estimated that 60,000 new patients are diagnosed each year. While the condition usually develops after the age of 65, 40 percent of people diagnosed are under age 60. Parkinson's disease affects nearly equal numbers of men and women, with no obvious social, ethnic, economic or geographic boundaries. There presently is no cure for the disease, and the cause is unknown.
Important Safety Information
Zelapar is contraindicated in patients with a known hypersensitivity to any formulation of selegiline or any of the inactive ingredients of Zelapar. Zelapar is also contraindicated for use with meperidine and should not be administered with the analgesic agents tramadol, methadone, and propoxyphene. Zelapar should not be used with the antitussive agent dextromethorphan and should not be administered along with other selegiline products.
Daily doses of Zelapar should not exceed 2.5 mg/day because of the risks associated with nonselective inhibition of MAO. In general, the combination of Zelapar and tricyclic antidepressants, as well as Zelapar and serotonin reuptake inhibitors, should be avoided. In clinical trials, the incidence of adverse orthostatic hypotension was higher in geriatric patients than in nongeriatric patients. Zelapar may potentiate the dopaminergic side effects of levodopa and may cause or worsen preexisting dyskinesia. Decreasing the dose of levodopa may improve this side effect. Zelapar should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
5.2 percent of patients discontinued Zelapar therapy due to adverse events (versus one percent with placebo). The most commonly observed adverse events reported during clinical trials were dizziness, nausea, pain, headache, insomnia, rhinitis, dyskinesia, back pain, skin disorders, stomatitis, and dyspepsia.
Zelapar is a registered trademark of Valeant Pharmaceuticals International or its related companies. All other trademarks are the trademarks or the registered trademarks of their respective owners.
SOURCE: Valeant Pharmaceuticals International
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