Neurocrine’s insomnia treatment accepted for FDA review

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 developed to address different types of sleep problems. Indiplon was licensed from DOV Pharmaceutical in 1998.

Insomnia is a prevalent condition in the US. According to the National Sleep Foundation’s “Sleep in America Poll 2005” approximately half of America’s adults report that they experienced at least one symptom of insomnia a few nights a week or more in the past year. Sleep loss has been found to impair the ability to perform tasks involving memory, learning, and logical reasoning, yet few people understand the importance of sufficient sleep.

Neurocrine and Pfizer jointly submitted an application for Indiplon to the FDA in May 2005. If the FDA accepts both applications for review, approval decisions could be made half way through 2006. This would have a great effect on the companies stock which would benefit from sales of Indiplon, potentially reaching $250 million from 2006 to 2008.