Upsher-Smith Laboratories Announces Initiation of Open-Label Extension Study of USL255 (Extended-Release Topiramate) for Adjunctive Treatment of Partial-Onset Epilepsy

MAPLE GROVE, Minn., Nov. 9, 2010 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. today announced the addition of an open-label extension study to PREVAIL, its global Phase III clinical trial for USL255 (extended-release topiramate). An internally developed program for the adjunctive treatment of adult epilepsy patients with partial-onset seizures, USL255 is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options.

"The open-label extension study will provide additional long term tolerability information regarding USL255 as adjunctive therapy in patients with refractory partial-onset seizures who completed the Phase III study and choose to participate in the extension study," said Alan Rauch, M.D., Chief Medical Officer and Vice President Medical & Regulatory Affairs. "We are pleased to offer these patients the opportunity to continue on or switch to USL255 at the conclusion of the Phase III clinical trial."

PREVAIL, the Phase III study, is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The PREVAIL study is entitled "Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-GRoup, Phase III Study to EVAluate the Efficacy and Safety of USL255 as Adjunctive Therapy In Patients with Refractory PartiaL-Onset Seizures."

About the Open-Label Extension Study

All patients completing the PREVAIL Phase III study will be eligible to enroll in the extension study, which continues to examine individuals aged 18 to 75 years with refractory partial-onset seizures with or without secondary generalized seizures. Laboratory evaluations, vital signs and physical examinations will be conducted at regular intervals to support patient safety.

Further information on this clinical study can be found at http://clinicaltrials.gov/ct2/show/NCT01191086?term=USL255+P09-005&rank=1

Upsher-Smith's Expanding CNS Pipeline

USL255 is the lead investigational drug in Upsher-Smith's expanding CNS development pipeline that includes three other investigational drug programs. In June 2010, the company obtained the exclusive global rights to intranasal midazolam as an orphan drug for the management of acute repetitive seizures (ARS) in patients with epilepsy. In April 2010, the company obtained exclusive rights in North America for the investigational drug tonabersat, a first-in-class neuronal gap junction modulator for the treatment of epilepsy. Upsher-Smith has also partnered with Proximagen Group Plc for the co-development and commercialization of the PRX1 program for the symptomatic treatment of Parkinson's disease.

About Epilepsy and Parkinson's Disease

Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. Almost three million people in the U.S. have some form of epilepsy with about 200,000 new cases of epilepsy diagnosed each year.(1)

Parkinson's disease is a chronic, progressive neurodegenerative disease that causes impairment in motor function, as well as many non-motor complications throughout the various stages of the disease. As many as 1 million people in the U.S. suffer from Parkinson's disease, with 1 in 100 people over the age of 60 affected.(2)

About Upsher-Smith

Upsher-Smith Laboratories, Inc., founded in 1919, is a rapidly growing, privately held pharmaceutical company that develops, manufactures, and markets prescription and over-the-counter products.  Upsher-Smith's product portfolio focuses in the areas of women's health, dermatology, cardiology, and central nervous system diseases. The company's growing CNS pipeline concentrates on diseases with significant unmet need, including epilepsy and Parkinson's disease. To expand its CNS pipeline, Upsher-Smith seeks alliances and co-development programs, pursues licensing and acquisitions, and leverages the development of its core competency in formulation development. For more information, visit www.upsher-smith.com.

1. Epilepsy Foundation. Available at: http://www.epilepsyfoundation.org/. Accessed on November 5, 2010.

2. The Michael J. Fox Foundation for Parkinson's Research. Available at: http://www.michaeljfox.org/. Accessed on November 5, 2010.

SOURCE Upsher-Smith Laboratories, Inc.