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

ight dose of Intermezzo®.  A secondary analysis that evaluated mean differences in SDLP between Intermezzo® and placebo administered three hours prior to driving showed a difference of 1.5 cm, which was statistically significant.

Driving data: 9 hours after dosing zopiclone at bedtime, the active controlZopiclone was studied to establish that the test design was capable of detecting driving impairment.  Zopiclone worked as expected, confirming the ability of the study to detect such impairment. The symmetry analysis showed statistically significant drug effect on driving performance in healthy subjects who began driving an automobile nine hours after receiving zopiclone at bedtime.  The mean difference in SDLP between zopiclone and placebo administered nine hours prior to driving showed a difference of 2.5 cm, which was statistically significant.

Three drives were terminated prematurely during the study due to excessive sleepiness.  One subject failed to complete two drives, one on the zopiclone treatment arm, the active control in the study, and the other on the Intermezzo® 3-hour treatment arm. A second subject failed to complete the drive in the zopiclone treatment arm.

Glenn A. Oclassen, Transcept President and Chief Executive Officer, said, "The findings from this highway driving study reinforce our belief that Intermezzo® has the potential to be the first FDA approved sleep medication for use as needed when a  middle of the night awakening is followed by difficulty returning to sleep.  If approved by the FDA, these results will further differentiate Intermezzo® from other sleep aids by providing physicians and their patients with important safety information from what we believe to be the largest highway driving study of its kind. This study is a central component of our broader resubmission strategy to address the concerns expressed by the FDA in
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SOURCE Transcept Pharmaceuticals, Inc.
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