Neurocrine Announces Acceptance of NDA for Indiplon Capsules

The FDA has accepted the Neurocrine Biosciences' new drug application (NDA) for indiplon capsules for review for the treatment of insomnia in both adult and elderly patients.

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.