Transcept Pharmaceuticals Presents Data at SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies
Analyses of Efficacy and Absence of Rebound Effect in a Clinical Study of Intermezzo(R) (Zolpidem Tartrate Sublingual Tablet 3.5 mg) to Treat Middle-of-the-Night (MOTN) Awakening on an As-Needed Basis
The first poster, titled “As-Needed Treatment of Insomnia Following MOTN Awakening: Clinical Efficacy of Low-Dose Zolpidem Tartrate Sublingual Tablet,” was presented on
In the study, 295 adults (aged 18 to 64 years) with insomnia characterized by MOTN awakenings and difficulty returning to sleep were randomized to receive four weeks of double-blind treatment with either ZST or placebo. Study medication was to be taken only when needed (prn) at the time of awakening with difficulty returning to sleep. The study included a two-week, single-blinded, placebo screening period. An interactive voice response system (IVRS) was utilized for patient data collection. Results indicated that, compared to placebo, 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 improved the post-MOTN sleep maintenance parameters of wake after sleep onset and number of awakenings versus placebo. The 3.5 mg zolpidem tartrate sublingual tablet was well tolerated and no safety issues were identified.
The second poster, titled “Absence of Rebound Effects with Low-Dose Zolpidem Tartrate Sublingual Tablet 3.5 mg As-Needed Use: Preliminary Analysis,” was presented on
On nights when medication was not taken, no rebound effects were seen, as determined by total sleep time, sleep latency at the beginning of the night and sleep quality. In the study, 65 percent of the patients did not take medication nightly and there was no evidence of increased utilization of drug over the four week treatment period.
About Transcept Pharmaceuticals
Transcept Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience. On
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Forward Looking Statements
This press release contains forward looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Transcept disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, the ability of merger proceeds to be sufficient to successfully commercialize Intermezzo(R) and the potential for Intermezzo(R) to receive timely FDA approval to be the first commercially available sleep aid specifically designed for use in the middle of the night and the expected benefits of Transcept product candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, a significant delay in FDA approval of Intermezzo(R); unanticipated additional expenses in connection with the commercialization of Intermezzo(R); Transcept product candidates may have unexpected adverse side effects or inadequate therapeutic efficacy; positive results in clinical trials may not be sufficient to obtain FDA approval; physician or patient reluctance to use Intermezzo(R), if approved; potential alternative therapies; maintaining adequate patent or trade secret protection without violating the intellectual property rights of others; and other difficulties or delays in, clinical development, obtaining regulatory approval, market acceptance and commercialization of Transcept product candidates.
Contacts: Transcept Pharmaceuticals, Inc. The Ruth Group Michael Gill Investors / Media Director of Communications Stephanie Carrington / Jason Rando (510) 215-3575 (646) 536-7017 / 7025 firstname.lastname@example.org email@example.com firstname.lastname@example.org
SOURCE Transcept Pharmaceuticals, Inc.