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Transcept Pharmaceuticals Announces Preliminary Results From the Intermezzo® Highway Driving Study
Date:10/18/2010

ug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in September 2008 seeking approval 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.  In October 2009, Transcept received a Complete Response Letter from the FDA on the Intermezzo® NDA.  In October 2010, Transcept announced preliminary results from the highway driving study of Intermezzo®.  Transcept plans to resubmit the Intermezzo® NDA in the first quarter of 2011, and anticipates a six-month review by the FDA. Transcept and Purdue Pharmaceutical Products L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo® in the United States.  Transcept is also developing TO-2061, an ultra low dose ondansetron augmentation therapy for patients with obsessive compulsive disorder (OCD) who have not adequately responded to treatment with SSRIs.  Transcept plans to begin a Phase 2 study of TO-2061 in 2011.  For further information, please visit the Transcept website at: www.transcept.com.

Forward-looking statementsThis press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the following: plans and timing estimates to resubmit the Intermezzo® NDA and complete regulatory review with the FDA; the ability of Transcept to resubmit the Intermezzo® NDA with sufficient content to warrant FDA approval; the types of data and other information expect
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SOURCE Transcept Pharmaceuticals, Inc.
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