FDA Hits Snooze Button on Neurocrine's Sleep Drug

Law360, New York (September 5, 2006, 12:00 AM EDT) -- Further clouding the future of insomnia drug Indiplon, Neurocrine Biosciences Inc. said on Tuesday that the FDA has asked it to reanalyze safety and efficacy data because of issues raised in an initial review.

The FDA initially approved two low-dose versions of Indiplon, but issued a non-approval letter for the higher and longer lasting 15-mg dose.

Indiplon is a drug that acts on a specific site of the GABA-A receptor in the brain believed to be responsible for promoting sleep.

The original application for Indiplon was...
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