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Phase I Research of Extended-Release Topiramate Shows Less Fluctuation in Plasma Levels
Date:4/11/2011

he 100 mg IR topiramate administered twice daily.  USL255 also showed a lower maximum plasma concentration than IR topiramate.  

USL255 is the subject of a global Phase III clinical trial (PREVAIL), being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), as well as an open-label extension study.

Upsher-Smith's Expanding CNS Pipeline

USL255 is the lead investigational drug in Upsher-Smith's expanding central nervous system (CNS) development pipeline, with an anticipated indication for the adjunctive treatment of adult epilepsy patients with partial onset seizures (POS).  USL's pipeline includes a number of other investigational drug programs.  Another program in this pipeline, USL261 (nasal midazolam), is under development for the management of cluster seizures in epilepsy.  Other programs include USL260 (tonabersat), an investigational drug and first-in-class neuronal gap junction modulator for the potential treatment of epilepsy.  Upsher-Smith has previously announced its partnership with Proximagen Group Plc for the PRX1 program for the symptomatic treatment of Parkinson's disease, in which Upsher-Smith is responsible for the world-wide development and commercialization of PRX1 under the direction of a joint steering committee on which there is representation of both Upsher-Smith and Proximagen.

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 one million people in the Uni
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SOURCE Upsher-Smith Laboratories
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