NEUROCRINE BIOSCIENCES ANNOUNCES PLANS TO RESUBMIT INDIPLON MODIFIED RELEASE NDA

Neurocrine Biosciences plans to resubmit its new drug application (NDA) for indiplon modified release (MR) tablets to update its electronic formatting.

The indiplon MR filing was submitted to the FDA in November 2004. Neurocrine previously reported that the NDA for indiplon immediate release (IR) capsules was not accepted by the FDA due to difficulties encountered in navigating the NDA in the electronic common technical document (CTD) format. The IR NDA included nonclinical, clinical and manufacturing information that was common to both the IR and MR applications.

The reformatting of the indiplon MR NDA will ensure technical consistency with the indiplon IR NDA since the two applications share CTD modules. The formatting issues are based on technical difficulties with the electronic navigation and do not pertain to the content of either the IR or MR filings.