Neurocrine Submits New Drug Application for Indiplon Capsules

Neurocrine Biosciences has submitted a new drug application (NDA) to the 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 (eCTD) format, originally submitted in late 2004, and did not pertain to the content of the filing.

The NDA for Indiplon tablets will also be resubmitted to the FDA in the second quarter to address similar formatting difficulties encountered with the eCTD 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.