Published on June 14, 2007 at 1:34 PM
Neurocrine Biosciences, Inc. has announced that they have resubmitted its New Drug Application (NDA) for indiplon 5 mg and 10 mg capsules for the treatment of insomnia in both adult and elderly patients to the U.S. Food and Drug Administration (FDA).
The resubmission is a complete response to the FDA's May 15, 2006 approvable letter. The indiplon NDA resubmission is based on analyses discussed with statistical, clinical and regulatory consultants. In addition the Company has had interactions with the FDA regarding additional analyses of data previously submitted on indiplon capsules.
"We are pleased to announce the resubmission of the NDA for indiplon capsules and we look forward to working with the FDA in the review process of our resubmission," said Gary A. Lyons, President and CEO of Neurocrine Biosciences. "We believe that indiplon's unique profile can offer an effective solution for those patients who need help getting to sleep or returning to sleep after a nighttime awakening."
Indiplon is a non-narcotic non-benzodiazapine agent that acts on a specific site of the GABA-A receptor and potentiates the action of GABA. While other drugs also act on this receptor, indiplon's mechanism is unique in that it has been shown to bind more selectively to the specific subtype of GABA-A receptors within the brain believed to be responsible for promoting sleep. Indiplon was licensed from DOV Pharmaceutical in 1998.
http://www.neurocrine.com/