Upsher-Smith completes USL255 Phase III clinical trial in patients with refractory POS

May 23 2013

Upsher-Smith Laboratories, Inc. today announced the successful completion of its global Phase III clinical trial for USL255 (extended-release topiramate), an internally developed program for the management of epilepsy in adults, using the company's proprietary formulation technology. USL255 is specifically engineered to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available treatment options. Upsher-Smith's New Drug Application for USL255 has been accepted for review by the U.S. Food and Drug Administration (FDA) with an anticipated target review date under the Prescription Drug User Fee Act (PDUFA) of December 2013.

In the study, USL255 demonstrated a positive treatment effect as adjunctive therapy in patients with refractory partial-onset seizures (POS) compared with placebo. USL255 had a statistically significant reduction from baseline in weekly POS frequency during the titration plus maintenance phase compared to placebo (p<0.001). Preliminary findings from the Phase III trial will be submitted for presentation at the 2013 Annual Meeting of the American Epilepsy Society, December 6-10 in Washington, D.C.

"We are very excited by the preliminary findings from this well-executed global trial. Sixty-nine centers enrolled more than 200 patients to evaluate the safety and efficacy of USL255, a uniquely designed extended-release formulation of topiramate," said Steve Chung, M.D., Professor of Neurology at the Barrow Neurological Institute, Phoenix and trial investigator.  "This study provides strong evidence suggesting that once-daily USL255 may be a therapeutic option for patients suffering from partial-onset seizures."

"The successful completion of the Phase III clinical trial of USL255 marks an exciting milestone in Upsher-Smith's focused strategy to develop and deliver therapies to address central nervous system disorders," said Mark Evenstad, President and CEO of Upsher-Smith. "Underpinning this strategy is our commitment to advancing pharmacotherapy to improve lives."