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

2.5 cm was specified in the protocol as the primary threshold of impairment for the purpose of performing the statistical analyses.  In March 2010, the FDA informed Transcept that the statistical methodology proposed by Transcept, a symmetry analysis, was a reasonable approach to measure potential next morning driving impairment.  

For reference, a 0.05% blood alcohol concentration has been associated with a change in SDLP of 2.4 cm, and a blood level of 0.08% has been associated with a mean change in SDLP of 4.2 cm (Brookhuis, Human Psychopharmacology: Clinical and Experimental, Vol. 13, 1998).  A blood alcohol concentration of 0.08% is the legal limit generally applicable for driving in the United States.

Driving data: 4 hours after middle of the night Intermezzo® dosing The 4-hour Intermezzo® treatment arm was included to represent dosing in accordance with proposed label instructions. The primary statistical analysis used in the Intermezzo® highway driving study, known as a symmetry analysis, showed no statistically significant drug effect on driving performance in subjects who began driving an automobile four hours after receiving a middle of the night dose of Intermezzo®.  A secondary analysis that evaluated mean differences in SDLP between Intermezzo® and placebo administered four hours prior to driving showed a difference of 0.8 cm, which was statistically significant.

Driving data: 3 hours after middle of the night Intermezzo® dosing The 3-hour arm was included in the study to help the FDA characterize the safety profile of Intermezzo® if it were not used as directed and taken with less than four hours before driving.  The symmetry analysis showed statistically significant drug effect on driving performance in subjects who began driving an automobile three hours after receiving a middle of the n
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SOURCE Transcept Pharmaceuticals, Inc.
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