IndiplonTreatment 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.
Posted: September 2006
- Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA - December 13, 2007
- Neurocrine Announces PDUFA Action Date of December 12, 2007 for Indiplon Capsules - August 22, 2007
- 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
- Neurocrine Announces Acceptance of New Drug Application for Indiplon Tablets - July 26, 2005
- Neurocrine Announces Acceptance of New Drug Application for Indiplon Capsules - June 14, 2005
- Neurocrine Announces Submission of New Drug Application for Indiplon Tablets - May 26, 2005
- Neurocrine Announces Submission of New Drug Application for Indiplon Capsules - April 14, 2005
- Neurocrine Biosciences Announces Resubmission Status of Indiplon - February 7, 2005
- Neurocrine Biosciences Announces Plans to Resubmit Indiplon Modified Release New Drug Application (NDA) - January 11, 2005
- Indiplon IR NDA (New Drug Application) to Be Reformatted Due to Difficulties in Accessing Portions of the Electronic NDA - December 21, 2004
- Neurocrine Submits New Drug Application (NDA) for Indiplon Modified Release Tablets for the Treatment of Insomnia - November 22, 2004
- Neurocrine Submits New Drug Application (NDA) for Indiplon Immediate Release Capsules for the Treatment of Insomnia - October 19, 2004