Sunovion Pharmaceuticals Inc. of Marlboro has filed a new application with the U.S. Food and Drug Administration for its experimental epilepsy drug Stedesa.
We are pleased to achieve this regulatory milestone for Stedesa, which, if approved, may offer adult patients living with epilepsy an effective, once-daily, adjunctive treatment option for managing partial-onset seizures, said Fred Grossman, senior vice president of clinical development and medical affairs at Sunovion, in a statement. Adequate seizure control of this most common form of epilepsy remains an unmet medical need for a significant number of patients and Sunovion is committed to providing a treatment option to help address this need.
The company said the application for Stedesa is supported by data from three clinical trials that included more than 1,300 patients with partial-onset seizures in 35 countries.
The most commonly reported adverse events were dizziness, somnolence, headache, nausea, double vision, vomiting, fatigue, ataxia, blurred vision and vertigo, officials added.
Sunovion originally sought FDA approval for Stedesa in March 2009. The drug is currently marketed as Zebinix in Europe by licensee Eisai Europe Ltd.
See more here:
Sunovion seeks FDA approval for epilepsy drug