Valeant Pharmaceuticals Receives FDA Approval of Zelapar
COSTA MESA, Calif., June 15, 2006 - Valeant Pharmaceuticals International 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(R) 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."
Zelapar Clinical Trial Overview
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. Patients received either 1.25 mg of the drug or placebo each day for the first six weeks and then 2.5 mg of the drug or placebo once-daily for the following six weeks. Zelapar was shown to significantly reduce "off" time after one week of treatment. At the end of 12 weeks, Zelapar treated patients had, on average, 2.2 hours per day less "off" time compared to baseline, and placebo-treated patients had 0.6 hours per day less "off" time. The observed reduction in "off" time between the two treatment groups compared to baseline was statistically significant (p less than 0.001).
The most common adverse events reported by patients treated with Zelapar were comparable to placebo and included nausea (11%), dizziness (11%), pain (8%), headache (7%), insomnia (7%), rhinitis (7%), dyskinesia (6%), skin disorders (6%), stomatitis (5%), back pain (5%) and dyspepsia (5%).
MAO inhibitors have been used as an adjunct therapy in Parkinson's disease since the first clinical trials of levodopa therapy in the early 1960s. Selegiline, the active ingredient in Zelapar, is an MAO-B inhibitor that prevents the breakdown of dopamine, the key neurotransmitter in the brain controlling movement. Using an innovative transbuccal drug delivery system called Zydis Technology, Zelapar Orally Disintegrating Tablets dissolve within seconds in the mouth and deliver more active drug at a lower dose. Zelapar is the first Parkinson's disease treatment to use Zydis, and due to its fast-disintegrating technology, Zelapar significantly bypasses the gut and first-pass hepatic metabolism. It is primarily absorbed into the systemic circulation 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. Serious, sometimes fatal reactions have been precipitated with the concomitant use of meperidine (e.g., Demerol and other tradenames) and MAO inhibitors including selective MAO-B inhibitors. These reactions have been characterized by coma, severe hypertension or hypotension, severe respiratory depression, convulsions, malignant hyperpyrexia, excitation, peripheral vascular collapse and death. In addition, the combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior. Severe toxicity has also been reported in patients receiving the combination of tricyclic antidepressants and conventional selegiline and selective serotonin reuptake inhibitors and conventional selegiline. Zelapar should not be administered along with other selegiline products.
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.
5.2 percent of patients discontinued Zelapar therapy due to adverse events (versus one percent with placebo). Zelapar should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
For full prescribing information, please visit www.zelapar.com.
Posted: June 2006