In October 2009, the FDA issued a Complete Response Letter in which it indicated that Transcept had submitted substantial evidence of effectiveness for the use of Intermezzo in its intended indication and that the data submitted did not indicate significant next-day residual effects at 4 hours. However, the FDA requested additional data on next-day effects, with particular reference to driving ability, and a demonstration that inadvertent patient dosing errors could be adequately minimized.
Transcept plans to resubmit the NDA for Intermezzo in the first quarter of 2011, and anticipates a 6-month review by the FDA. In the revised NDA, Transcept plans to address FDA concerns raised in the Complete Response Letter by submitting a revised unit dose package, new patient tools to reinforce the importance of proper dosing, new epidemiology findings that quantify the current off-label use of 7- to 8-hour hypnotics in the middle of the night, and the results of the highway driving study.
“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,” said Thomas Roth, PhD, director, Sleep Disorders and Research Center, Henry Ford Hospital. “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 4 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."