Transcept Pharmaceuticals to Report Second Quarter 20...(reviewed by the U.S. Food and Drug Admin...),Health

Date:8/6/2009

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.

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 w
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SOURCE Transcept Pharmaceuticals, Inc. Copyright©2009 PR Newswire. All rights reserved

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