Article: NEUROCRINE FILES NDA FOR IMMEDIATE-RELEASE INDIPLON.(Neurocrine Biosciences Inc.)

Article from:
BIOWORLD Today
Article date:
October 20, 2004
Author:
Copyright

Byline: Aaron Lorenzo, Senior Staff Writer

Eyeing a sliver of light at the end of the drug development tunnel, Neurocrine Biosciences Inc. submitted a new drug application for indiplon immediate-release capsules for insomnia.

The submission marks the first FDA filing in the history of the San Diego-based company, and also begins the final process in moving the long-studied product toward the market.

Neurocrine has tested immediate-release indiplon in seven Phase III trials, results from which are included in the NDA. Such safety and efficacy findings stem from studies conducted in adult and elderly patients with transient and chronic ...

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