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. 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 May 20, 2009 by Eric Hollander, M.D., Director, Neuropharmacology Services, LLC and former Esther and Joseph Klingenstein Professor and Chair of Psychiatry at the Mount Sinai School of Medicine. The pilot study, which involved 14 patients with a DSM-IV diagnosis of treatment resistant obsessive compulsive disorder (OCD) and under stable treatment with selective serotonin reuptake inhibitors (SSRIs) and neuroleptic augmentation, aimed to evaluate the potential of ondansetron augmentation as an alternative treatment for OCD.
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.
Glenn Oclassen, President and Chief Executive Officer of Transcept Pharmaceuticals, commented, "The posters presented by Dr. Rosenberg and Dr. Hollander lend further support to the Transcept strategy of deriving significant new patient benefits from proven drugs to address significant unmet medical needs. We are honored to have the opportunity to collaborate with such renowned researchers as Drs. Russell Rosenberg and Eric Hollander."
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 January 30, 2009, Transcept completed a merger with Novacea, Inc. As part of the transaction, Novacea changed its name to "Transcept Pharmaceuticals, Inc." and its NASDAQ ticker symbol to "TSPT." The combined company resources resulting from the merger are expected to enable Transcept to successfully commercialize its lead product candidate, Intermezzo(R). If approved as anticipated, Intermezzo(R) would be the first commercially available sleep aid designed specifically for use in the middle of the night when patients awaken and have difficulty returning to sleep. Intermezzo(R) Phase 3 clinical trials have been completed and, on September 30, 2008, Transcept submitted a New Drug Application (NDA) for Intermezzo(R) to the U.S. Food and Drug Administration (FDA), which was accepted for filing on December 15, 2008. The FDA has assigned a PDUFA date of July 30, 2009 to the Intermezzo(R) NDA.
For further information, please visit the company's website at: www.transcept.com.
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.|
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