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This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Supernus' anti-epileptic advances to Phase III: Supernus initiates the pivotal Phase III trial for its lead product Epliga, a controlled-release formulation of oxcarbazepine (Novartis' Trileptal and generics) designed to improve compliance and reduce adverse events compared with the marketed versions of the anti-epileptic drug, the company announces Dec. 17. The double-blind, placebo-controlled, randomized trial will evaluate once-daily Epliga for adjunctive treatment of refractory partial onset seizures. Supernus reported that Epliga showed significant improvement in key adverse events versus the reference product, Trileptal, in a proof-of-concept study. Supernus can expect that any potential Epliga labeling would include an FDA-mandated warning on the risk of suicidality in patients taking anti-epileptic drugs, and would be accompanied by a Medication Guide (1"The Pink Sheet," Jan. 5, 2009, p. 5). The experience Supernus gains from the Epliga Phase III should stand it in good stead as the company prepares for pivotal trials of another once-daily anti-epileptic drug formulation, Trokesa (topiramate controlled-release), which is expected to enter Phase III in 2009. Supernus' pipeline itself is something of a reformulation: the company's current incarnation dates to December 2005, when it purchased the drug formulation business of Shire Laboratories

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