Neurocrine Biosciences, Inc. has submited a New Drug Application (NDA) to the US Food and Drug Administration for indiplon tablets for the treatment of insomnia in both adult and elderly patients.

The NDA for indiplon capsules was submitted to the FDA in April of 2005. These filings are based on clinical data supporting that both indiplon capsules and tablets show significant improvement in all sleep onset, sleep maintenance and sleep quality parameters.

Indiplon is a unique, non-narcotic, non-benzodiazapine agent that acts on a specific site of the GABA-A receptor. Indiplon has been shown to bind 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. Upon approval, indiplon will be copromoted in the US with Pfizer.

"The indiplon NDA submissions are supported by data from one of the most comprehensive clinical trial programs conducted in insomnia which showcased the consistency with which indiplon helps patients address sleep onset and sleep maintenance problems while improving overall sleep quality," said Gary A. Lyons, President and CEO of Neurocrine Biosciences.