Pharmaceutical News and Articles

Indiplon

NBI-34060

Treatment for Insomnia

Neurocrine Biosciences Announces Plans to Resubmit Indiplon Modified Release New Drug Application (NDA)

SAN DIEGO, January 11, 2005 -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced today that the Company will 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 U.S. Food and Drug Administration (FDA) on November 22, 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 non-clinical, 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.

"We will be meeting with the FDA in late January to discuss our electronic reformatting changes and to finalize the filing strategies. Based on this meeting, we plan to submit both the IR and MR applications as soon as possible. We anticipate only a modest impact on the expected timelines for approval and launch of indiplon," said Gary A. Lyons, President and CEO of Neurocrine Biosciences.

The Division of Neuropharmacological Drug Products is now responsible for the indiplon review and approval process. The filing contains studies which comprise one of the most extensive programs conducted to date in insomnia, with data from 68 clinical trials and over 80 preclinical studies and includes a comprehensive safety and efficacy evaluation in over 7500 subjects. The NDAs were filed in eCTD electronic format, which contain approximately 1500 volumes or 524,000 pages of data.

Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, and autoimmunity.
For more information, please visit www.neurocrine.com.

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