Neurocrine reviews FDA's indiplon letters

USA-based Neurocrine Biosciences has completed its review of the action letters it received from the Food and Drug Administration regarding indiplon. When the FDA announced it would not approve the extended release 15mg form of the insomnia drug, shares in the San Diego-headquartered firm plummeted and had declined 62% a week later (Marketletter May 22).

During the past month, the company has been preparing a briefing document to submit to the agency, which it hopes will clarify its understanding of the issues raised. The action letters included an approvable letter for 5mg and 10mg immediate-release indiplon capsules, which requested re-analysis of certain preclinical and clinical studies to support approval for sleep initiation and middle-of-the-night dosing. The FDA also requested re-examination of the safety analysis for the elderly population and may require additional clinical and/or preclinical safety data, the firm noted.