Transcept Pharmaceuticals, Inc. today announced that it has resubmitted
its New Drug Application (NDA) to the 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.”
