Pharmaceutical News and Articles

Indiplon

NBI-34060

Treatment for Insomnia

Neurocrine Reports Results of FDA End-of-Review Meeting on Indiplon Capsules NDA

SAN DIEGO, September 5, 2006 -- Neurocrine Biosciences, Inc. today reported the results of its end-of-review meeting with the Food and Drug Administration (FDA) meeting for the indiplon capsules New Drug Application (NDA). The meeting with the FDA was specifically focused on determining the actions needed to bring indiplon immediate-release (IR) capsules from Approvable to Approval for the treatment of insomnia.

The Company summarized the results of the FDA meeting as follows:

The FDA requested that the Company supplement the pharmacokinetic/food effect profile of indiplon (IR) capsules to include several meal types.
The Company will initiate such a study shortly after further consultation with the FDA. No other clinical trials were requested for the re-submission;
The re-submission will also include further analyses and modifications of analyses previously submitted which address questions raised by the agency in the initial review.

"We are pleased to have clarified the outstanding issues with the FDA and expect to resolve the remaining issue in the coming weeks," said Gary A. Lyons, President and Chief Executive Officer of Neurocrine Biosciences. "Subject to those further consultations with the FDA we are expecting to provide a complete re-submission sometime before the end of the 2nd Qtr 2007. We are encouraged about the prospects for indiplon capsules to compete effectively in the marketplace upon approval and continue to evaluate alternatives for bringing it to market in a timely manner."

Separately, the Company has also confirmed that its request for an end-of- review meeting with the FDA to discuss and clarify action items for indiplon (MR) tablets has been scheduled towards late October 2006.

Source: Neurocrine Biosciences, Inc.

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Neurocrine Announces Resubmission of New Drug Application for Indiplon Capsules - June 13, 2007

Neurocrine Completes Review of Indiplon Action Letters - June 15, 2006

Neurocrine Receives Approvable Letter for indiplon Capsules and Non-Approvable for indiplon Tablets for the Treatment of Insomnia - May 16, 2006

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Neurocrine Announces Submission of New Drug Application for Indiplon Capsules - April 14, 2005

Neurocrine Biosciences Announces Resubmission Status of Indiplon - February 7, 2005