Supernus Pharmaceuticals Initiates Phase III Clinical Trial For Epliga™ In Refractory Partial Onset Epileptic Seizures

Main Category: Epilepsy
Also Included In: Clinical Trials / Drug Trials
Article Date: 24 Dec 2008 - 1:00 PDT

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Supernus Pharmaceuticals, Inc. 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 novel 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.

About Supernus

Supernus Pharmaceuticals, Inc. is focused on developing specialty CNS products that are designed to improve patient compliance, reduce side effects, and address unmet medical needs. The company's extensive expertise in product development is well proven over the past 18 years. Supernus started its operations in December 2005 when it purchased significantly all the assets of Shire Laboratories, Inc. including technologies, intellectual property, and product partnerships. Products using the technologies and expertise of Supernus, and when formerly Shire Laboratories, include: Adderall XR®, Carbatrol® and Equetro® that are marketed by Shire or its sub-licensees, Oracea® that is marketed by Galderma, and Sanctura® XR that is marketed by Allergan in the U.S.

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Supernus Pharmaceuticals, Inc