FDA Announces New Drug Application for Review
February 27, 2013
The New Drug Application (NDA) resubmission for STEDESA® (eslicarbazepine acetate), an adjunctive therapy in the treatment of partial onset seizures in patients 18 years and older, has been accepted for review by the U.S. Food and Drug Administration (FDA), indicating that the application is sufficiently complete to permit a substantive review.
"The epilepsy community is excited about the FDA's decision to review the NDA resubmission for STEDESA® (eslicarbazepine acetate)," said Dr. Joseph Sirven, Chair of the Epilepsy Foundation's Professional Advisory Board and Editor-in-Chief of epilepsy.com. "We are thankful that the FDA will consider the benefits of novel therapeutics such as STEDESA® in helping people with difficult to control epilepsy."
The most common side-effects of three Phase III randomized, double-blinded, placebo-controlled, 12-week maintenance trails were dizziness, somnolence, blurred vision, vomiting, nausea, headaches, fatigue, ataxia and vertigo. More than 1,300 patients with partial-onset seizures from around the world participated in this trial.
The original NDA of STEDESA® was submitted to the FDA in March 2009. Sunovion Pharmaceuticals prepared the current submission.