Intermezzo data drive Transcept toward revised NDA

Transcept Pharmaceuticals Inc. (NASDAQ:TSPT) plans to resubmit an NDA for Intermezzo zolpidem next quarter after the insomnia candidate produced no significant next morning effects on driving performance at four hours after middle of the night dosing in a Phase I trial in 40 healthy volunteers. Performance was measured by standard deviation of lateral position (SDLP) change in a highway driving lane based on a symmetry analysis. Based on a review of published literature, an SDLP change of 2.5 cm was specified in the protocol as the primary threshold of impairment for statistical analyses, which the company said is about equal to the mean increase in SDLP reported to occur with a blood alcohol concentration of 0.05%. FDA previously informed Transcept that the symmetry analysis was a "reasonable approach" to measure potential next morning driving impairment.

Transcept's proposed labeling for the low-dose sublingual formulation of zolpidem states that patients have at least four hours remaining in bed after middle of the night dosing. SDLP was measured as subjects drove a car at 60 mph for 62 miles on a public highway under normal traffic conditions. ...