Transcept Pharmaceuticals, Inc. announced that it has resubmitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of Intermezzo for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.
Transcept expects that the Intermezzo NDA resubmission, if accepted and deemed complete by the FDA, will be subject to a Class 2 six-month review.
The Intermezzo resubmission package is intended to address issues raised in the October 2009 FDA Complete Response Letter. New information contained in the resubmission package includes data and analyses from the recently completed Intermezzo highway driving study, a comparative review of data from previous driving studies of sleep aids and other medications, and redesigned product packaging and instructional tools. The resubmission also includes a recent epidemiology study that demonstrates the widespread use of 7 to 8 hour hypnotic drugs in the middle of the night, despite the fact that these products have been approved only for bedtime dosing.
"If approved, we anticipate that Intermezzo will be the first prescription sleep aid for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep," said Glenn A. Oclassen, president and chief executive officer of Transcept Pharmaceuticals. "We plan to work closely with the FDA through the resubmission process and are fully committed to making this important therapeutic option available to insomnia patients."
Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience.