ZelaparTreatment for Parkinson's Disease
Valeant Pharmaceuticals Submits Complete Response to FDA Approvable Letter for Zelapar
COSTA MESA, Calif., January 5, 2005 - Valeant Pharmaceuticals International (NYSE: VRX) today announced that it has recently submitted a complete response to an approvable letter from the U.S. Food and Drug Administration (FDA) for Zelapar (selegiline) following the successful completion of two safety studies required for Zelapar's approval. Valeant expects the FDA to complete its review within six months from the date of submission.
"We are pleased to complete the submission of this NDA," Valeant's chief executive officer, Timothy C. Tyson said. "The two safety studies conducted in response to the FDA's approvable letter were successfully completed over the past several months and the results are in line with our expectations. Zelapar is an important pipeline candidate for Valeant, which we expect to make available to the market by mid-2005."
Zelapar (selegiline hydrochloride) is a late-stage candidate under review by the FDA as an oral tablet using the patented Zydis fast-dissolving technology and is being developed as an adjunct treatment in the management of patients with Parkinson's disease being treated with levodopa/carbidopa.
Important Safety Information
Zelapar is contraindicated in patients who are hypersensitive to selegiline or any of the inactive ingredients of the drug product. Zelapar is also contraindicated for use with medperidine (Demerol). This latter contraindication is often extended to other opioids. The occurrence of stupor, muscular rigidity, severe agitation, and elevated temperature has been reported in some patients receiving the combination of selegiline and meperidine. Symptoms usually resolve over days when the combination is discontinued. Other serious reactions (including hallucinations and death) have been reported in patients receiving this combination. 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.
The most commonly observed adverse events, which were greater than placebo, reported in the double-blind, placebo-controlled trials during Zelapar treatment were dizziness, nausea, pain, headache, insomnia, rhinitis, dyskinesia, back pain, stomatitis, and dyspepsia. Zelapar should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Valeant Pharmaceuticals International (NYSE: VRX) is a global, publicly traded, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets a broad range of pharmaceutical products.
Posted: January 2005
- Zelapar Valeant Pharmaceuticals International - Treatment for Parkinson’s Disease - June 14, 2006
- Valeant Pharmaceuticals Receives Approvable Letter from FDA Regarding Zelapar - October 4, 2005