Neurocrine plans additional indiplon study to support FDA application

By Lisa Kerner

Charlotte, N.C., Sept. 5 - Neurocrine Biosciences, Inc. will begin a study of insomnia drug indiplon immediate-release capsules to include several meal types, as a result of its end-of-review meeting with the Food and Drug Administration.

The San Diego-based biopharmaceutical company said it will submit the supplemental pharmacokinetic/food effect profile of indiplon, along with further analyses and modifications of analyses previously submitted as requested by the FDA by the end of the second-quarter 2007.

Separately, the company said it plans an end-of-review meeting with the FDA to discuss and clarify action indiplon (MR) tablets in late October.

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