Upsher-Smith Laboratories Presents Extended-Release Topiramate Data (USL255) at ANA Meeting

MAPLE GROVE, Minn., Sept. 26, 2011 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. [http://www.upsher-smith.com] today announced the presentation of Phase I data showing that once daily administration of USL255, a proprietary extended-release (ER) formulation of the epilepsy medication topiramate, demonstrated equivalent topiramate exposure to immediate-release (IR) topiramate dosed twice daily.

These findings were presented Monday, September 26, at the American Neurological Association's (ANA) 2011 Annual Meeting in San Diego, CA.  [http://www.aneuroa.org]  The poster (M710), "Pharmacokinetic Equivalence between Immediate-Release and Extended-Release Topiramate," First Author:  Lawrence J. Lambrecht, PharmD, will be available electronically through iPosters interactive kiosks on site.

"Fluctuations in plasma levels can cause challenges for patients with epilepsy.  USL255 was shown to have an equivalent extent of exposure to immediate release topiramate while demonstrating an improved plasma profile.  We are excited to share this Phase I data and USL255's encouraging pharmacokinetic profile with clinicians at ANA," said Mark Halvorsen, Pharm.D., Senior Director, Clinical Development at Upsher-Smith.

USL255 is an investigational treatment being developed for the management of epilepsy in adults and is also the subject of a global Phase III clinical trial (PREVAIL).  Information about the trial can be found at: http://clinicaltrials.gov/ct2/show/NCT01142193?term=upsher+smith&rank=4

About The Study

In this Phase I, randomized, single-dose, crossover study, 36 healthy subjects received three different treatments (200 mg of USL255 under fasting conditions; 200 mg of USL255 under fed conditions; or 2 doses of 100 mg IR topiramate dosed 12 hours apart).  Based on pharmacokinetic measurements and using standard bioequivalence criteria, the authors determined that the overall extent of absorption of USL255 was equivalent to IR topiramate.  Additionally, absorption of USL255 was unaffected by food.  However, the presence of food was associated with a delay in the time to maximal plasma concentration of topiramate, a finding that was deemed consistent with the food effect on IR topiramate pharmacokinetics.

Upsher-Smith's Expanding CNS Pipeline

Upsher-Smith's central nervous system (CNS) pipeline includes a number of investigational drug programs.  In addition to USL255 (extended-release topiramate), USL is developing an intranasal midazolam (USL261), for the rescue treatment of seizures in patients on stable anti-epileptic drug regimens who require control of intermittent bouts of increased seizure activity, frequently referred to as seizure clusters.  Another program is USL260 (tonabersat), an investigational drug and first-in-class neuronal gap junction modulator which is also a potential treatment for epilepsy.

About Epilepsy

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)

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 consumer products.  Upsher-Smith's product portfolio focuses in the areas of women's health, dermatology, cardiology, and CNS diseases.  The company's focus is growing a CNS pipeline for 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 its core competency in formulation development.  For more information, visit http://www.upsher-smith.com.

(1) Epilepsy Foundation. Available at: http://www.epilepsyfoundation.org/.   Accessed on March 18, 2011.

SOURCE Upsher-Smith Laboratories, Inc.