Neurocrine Biosciences, Inc. has submitted a New Drug Application (NDA) to the US FDA for indiplon capsules for the treatment of insomnia in both adult and elderly patients. The filing was resubmitted to the FDA solely to address formatting difficulties with the electronic common technical document (e-CTDformat), originally submitted in late 2004, and did not pertain to the content of the filing, a company release stated.

"Insomnia takes a significant toll on the physical well-being, and emotional health of sufferers. This submission marks a major milestone in our commitment to provide people with a safe and effective treatment option," Gary A. Lyons, President and CEO of Neurocrine Biosciences said adding, "We believe that indiplon is an important advancement in the treatment of insomnia because it can provide the flexibility to address the individual sleep needs of people with insomnia for short or longer-term use."

The NDA for indiplon tablets will also be resubmitted to the FDA in the second quarter to address similar formatting difficulties encountered with the e-CTD format originally submitted in late 2004. Data from a recently completed clinical trial demonstrating the safety and efficacy of indiplon 15 mg tablets in adult patients will be added to the submission.

The indiplon NDA filings will contain data from 72 clinical trials and include a comprehensive safety and efficacy evaluation in more than 7,500 subjects. Clinical trial results have shown that indiplon capsules and tablets help patients consistently fall asleep faster, increase the amount of time they sleep during the night, decrease number of nighttime awakenings and improve overall sleep quality over the course of short or long-term treatment without evidence of next day effects.

Indiplon is a unique 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 developed to address different types of sleep problems. Indiplon was licensed from DOV Pharmaceutical in 1998. Upon approval, indiplon will be copromoted in the US with Pfizer, the release said.