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Data Suggests Positive Pharmacokinetic Results From Phase I Research of Extended-Release Topiramate
Date:12/6/2010

sma concentration than IR topiramate.  

"We are excited about the progress we have made in our development of USL255 and encouraged that USL255 may offer an improved PK profile compared with IR topiramate," Halvorsen added.  "We are committed to the development of USL255 for patients with refractory partial-onset seizures as part of USL's ongoing commitment to become a leader in providing therapies that empower people suffering from CNS diseases to lead healthy, productive lives."

In a related development, Upsher-Smith recently announced the addition of an open-label extension study of its ongoing global Phase III clinical trial (PREVAIL) for USL255.  The Phase III clinical trial is currently being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

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 increased bouts of seizure activity, including acute repetitive seizures and seizure clusters, 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.


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