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Transcept Pharmaceuticals Presents Data from Studies of Two Product Candidates at Annual Meeting of the American Psychiatric Association
Date:5/21/2009

Safety and Efficacy Study of Zolpidem Tartrate Sublingual Tablet in Treating Middle-of-the-Night Awakening on an As-Needed Basis

Evaluation of Ondansetron Augmentation in the Treatment of Obsessive Compulsive Disorder

RICHMOND, Calif., May 21 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, announced today the presentation of two posters at the 2009 annual meeting of the American Psychiatric Association in San Francisco, California.

The first poster, titled "Low-Dose Zolpidem Tartrate Sublingual Tablet Safely and Effectively Treats Insomnia Following MOTN Awakening," was presented on May 20, 2009 by Russell Rosenberg, PhD, D.ABSM, Founder and Director of NeuroTrials Research and the Atlanta School of Sleep Medicine. The intent of the study was to evaluate the safety and efficacy of 3.5 mg zolpidem tartrate sublingual tablet (ZST) when taken on an as-needed (prn) basis for the treatment of middle-of-the-night (MOTN) awakenings.

In the study, 294 adults (aged 18 to 64 years) with DSM-IV primary insomnia characterized by MOTN awakenings were randomized to four weeks of prn double-blind treatment with either ZST 3.5 mg or placebo, after a two-week interactive voice response system (IVRS) single-blind placebo screening. Results indicated that compared to placebo, 3.5 mg ZST significantly reduced latency to sleep onset after MOTN awakenings and improved sleep quality and next-day alertness ratings throughout the treatment period. Furthermore, ZST significantly improved the post-MOTN sleep maintenance parameters of wake after sleep onset and number of awakenings versus placebo.
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SOURCE Transcept Pharmaceuticals, Inc.
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