Upsher-Smith commences global USL255 Phase III clinical trial for management of epilepsy

Upsher-Smith Laboratories, Inc. today announced the initiation of a 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 designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options.

"The initiation of the Phase III trial for USL255 is a key milestone in Upsher-Smith's vision of becoming a leader in the CNS field," said Alan Rauch, M.D., Chief Medical Officer and Vice President Medical & Regulatory Affairs.  "There is a significant unmet need in the treatment of epilepsy, with as many as 30 percent of patients not adequately controlled using current antiepileptic drugs.  Poor medication compliance may be a contributing factor, and we are excited about the potential for USL255 to offer patients and clinicians a new treatment option with the potential for improved compliance."

The Phase III trial is a randomized, multinational, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of USL255 in patients 18 to 75 years of age with refractory partial-onset seizures with or without secondary generalized seizures.  

USL255 is the lead investigational drug in Upsher-Smith's expanding CNS development pipeline that includes two other investigational drug programs.  In April 2010, the company obtained exclusive rights in North America for the investigational drug tonabersat, a first-in-class neuronal gap junction modulator. Based on results of preclinical models of seizures, Upsher-Smith will focus on development of tonabersat for the treatment of epilepsy. In July 2008, Upsher-Smith entered into a worldwide licensing agreement with Proximagen Neuroscience Plc for the development and commercialization of the PRX1 program for the symptomatic treatment of Parkinson's disease.