Supernus Initiates Phase III Clinical Trial for Epliga™ in Refractory Partial Onset Epileptic Seizures
News Dec 29, 2008
Supernus Pharmaceuticals, Inc. has announced the initiation of the pivotal Phase III clinical trial for its lead product Epliga™. The trial is a randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of Epliga for the adjunctive treatment of refractory partial onset seizures in patients with epilepsy.
Epliga is a controlled release once-per-day dosage form of oxcarbazepine that is designed to improve compliance and reduce adverse events. Earlier this year, Supernus completed a proof-of-concept study where Epliga showed significant improvement in key adverse events compared to the reference product Trileptal®.
“Initiating our Phase III trial for Epliga is a major milestone for Supernus and an important step toward addressing a significant unmet need in the treatment of epilepsy,” said Jack Khattar, president and CEO.
“We are excited about Epliga and its potential for offering epilepsy patients an effective anti-convulsant therapy with much-needed lower side effects and the convenience of once-per-day dosing. Reaching this clinical development milestone for Epliga demonstrates the significant progress Supernus has made in the three years since we started building our pipeline,” Khattar said.