Transcept Pharmaceuticals Presents Data from Studies of Two Product Candidates at Annual Meeting of the American Psychiatric Association
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
The first poster, titled “Low-Dose Zolpidem Tartrate Sublingual Tablet Safely and Effectively Treats Insomnia Following MOTN Awakening,” was presented on
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. The 3.5 mg zolpidem tartrate sublingual tablet was well tolerated and no safety issues were identified.
The second poster, titled “Ondansetron Augmentation in Treatment Resistant OCD: A Preliminary Single-Blind Prospective Study,” was presented on
Following a 12-week single blind trial of ondansetron initiated at a dose of 0.25 mg twice daily for six weeks, and titrated to 0.5 mg twice daily for six weeks, results demonstrated that nine of 14 subjects (65 percent) experienced a treatment response at 12 weeks based on a score of greater than or equal to 25 percent reduction in the Yale Brown Obsessive Compulsive Scale (YBOCS). The average reduction in YBOCS-rated symptoms of the whole group was 23.2 percent. According to the researchers, the results suggested that low-dose ondansetron may have promise as an alternative treatment strategy for some patients suffering from OCD resistant to SSRIs and antipsychotic augmentation. None of the treated patients experienced symptom exacerbation or significant side effects.
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 email@example.com firstname.lastname@example.org email@example.com
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