RICHMOND, Calif., Aug. 26 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced that it will present at two upcoming healthcare investor conferences.
A live audio webcast and replay of the presentations will be available on the investor webpage at www.transcept.com.
Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience. The most advanced Transcept product candidate is Intermezzo(R) (zolpidem tartrate sublingual tablet), which is currently being reviewed by the U.S. Food and Drug Administration (FDA) as a prescription sleep aid for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. October 30, 2009 is the PDUFA target date for the FDA to take action on its review of the Intermezzo(R) NDA. Transcept and Purdue Pharmaceutical Products, L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo(R) in the United States. For further information, please visit the company's website at: www.transcept.com.
Intermezzo(R) (zolpidem tartrate sublingual tablet), the lead product candidate at Transcept, has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Intermezzo(R) is a sublingual low dose formulation of zolpidem, the active agent most commonly prescribed in the United States for the treatment of insomnia. Intermezzo(R) uses approximately one-quarter to one-third of the dose of active drug contained in currently marketed zolpidem-based sleep aids, in a formulation designed to promote rapid sublingual absorption. Transcept believes that Intermezzo(R), by combining the reduced zolpidem dose with administration only on those nights when a middle of the night awakening actually occurs, has the potential to reduce unnecessary sedative-hypnotic exposure.
Two Phase 3 clinical studies evaluated 376 patients receiving either Intermezzo(R) or placebo. In the first study, a sleep laboratory trial using an objective polysomnographic endpoint, Intermezzo(R) demonstrated a statistically significant decrease versus placebo in the time it took patients to return to sleep as measured by Latency to Persistent Sleep. In the second study, an outpatient trial, Intermezzo(R) demonstrated a statistically significant decrease in Latency to Sleep Onset, a subjective patient reported endpoint. The most common adverse event seen in these trials was headache (2.7 percent active versus 1.4 percent placebo in the outpatient study).
The FDA has established October 30, 2009 as its target date under PDUFA to take action on its review of the NDA. Transcept is actively pursuing patents to protect Intermezzo(R) in the United States and key non-U.S. markets, and, as part of the NDA submission, has requested that the FDA grant three years of Hatch-Waxman marketing exclusivity to Intermezzo(R).
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 potential for Intermezzo(R) to be the first prescription sleep aid specifically approved by the FDA for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep and the potential for the use of Intermezzo(R) to reduce unnecessary sedative-hypnotic exposure in the insomnia patient population. 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, whether FDA determines that the Intermezzo(R) NDA is sufficient to approve Intermezzo(R) for its intended indication and any delays in, and the final form of, any FDA approval of Intermezzo(R); the commercial success of Intermezzo(R), if approved; physician or patient reluctance to use Intermezzo(R), if approved; potential alternative therapies; obtaining and maintaining adequate patent or trade secret protection without violating the intellectual property rights of others; obtaining and maintaining Hatch-Waxman exclusivity for Intermezzo(R) and other difficulties or delays in, clinical development, market acceptance and commercialization of Intermezzo(R).
|SOURCE Transcept Pharmaceuticals, Inc.|
Copyright©2009 PR Newswire.
All rights reserved