Oct 19, 2010 - Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced its preliminary analysis of data from the recently completed Intermezzo(R) 3.5 mg (zolpidem tartrate sublingual tablet) highway driving study. Transcept is developing Intermezzo(R) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. In the Intermezzo(R) New Drug Application (NDA), Transcept proposed to the U.S. Food and Drug Administration (FDA) that patients have at least four hours remaining in bed after dosing Intermezzo(R) in the middle of the night.About the Intermezzo(R) highway driving study
The Intermezzo(R) highway driving study was a double-blind, randomized, placebo-controlled, four-way crossover study of 40 healthy volunteers designed to evaluate the safety profile of Intermezzo(R) with regard to next morning driving. The study evaluated standard deviation of lateral position (SDLP) in a highway driving lane, a surrogate measure for driving performance, as subjects drove an automobile 100 km, or 62 miles, on a public highway under normal traffic conditions for approximately one hour. Subjects performed test drives on placebo, zopiclone as a positive control taken at bedtime nine hours before driving, Intermezzo(R) taken three hours before driving, and Intermezzo(R) taken four hours before driving. Based on a review of the published literature, an SDLP change of 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... Transcept Pharmaceuticals' Press Release -
