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

the October 2009 Complete Response Letter."

Thomas Roth, Ph.D., Director, Sleep Disorders and Research Center, Henry Ford Hospital, said, "This study represents a robust approach to characterizing the effect of a sleep aid candidate on next morning driving ability, and serves as a model for the future testing of medication driving safety.  Findings from the highway driving study provide good evidence to support the view that Intermezzo® shows no significantly increased risk of driving impairment when taken with at least four hours remaining in bed.  Intermezzo® has the potential to be an important treatment for those insomnia patients whose only current option to treat a middle of the night awakening is to take a 7 to 8 hour sleep aid at bedtime in anticipation of an awakening that may not occur."

Transcept plans to resubmit the Intermezzo® NDA in the first quarter of 2011, and anticipates a six-month review by the FDA.  In the revised NDA, Transcept plans to address FDA concerns raised in an October 2009 Complete Response Letter by submitting the results of the highway driving study, a revised unit dose package, new patient tools to reinforce the importance of proper dosing, and new epidemiology findings that quantify the current off-label use of 7 to 8 hour hypnotics in the middle of the night.

Transcept estimates that cash, cash equivalents and marketable securities at September 30, 2010 were approximately $74 million, and believes these resources will be sufficient to allow for the resubmission of the Intermezzo® NDA and to complete the planned placebo-controlled study of ultra low dose ondansetron as an adjunctive treatment of obsessive compulsive disorder.

About the Intermezzo® Development Program Transcept completed pre-clinical and clinical studies of Intermezzo®, including two Phase 3 clinical trials, in 2008.  The
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SOURCE Transcept Pharmaceuticals, Inc.
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