IndiplonTreatment for Insomnia
Neurocrine Completes Review of Indiplon Action Letters
SAN DIEGO, June 15, 2006 -- Neurocrine Biosciences, Inc. announced that the Company has completed its review of the indiplon action letters and has requested a meeting with the Food and Drug Administration (FDA). During the past several weeks the Company has been preparing a briefing document which will be submitted to the FDA. This briefing document will assist the Company in articulating its understanding of the issues communicated by the FDA in the May 15th action letters. The action letters included an Approvable Letter for 5 mg and 10 mg immediate release indiplon capsules and a Not Approvable Letter for indiplon 15 mg extended release tablets received by the Company on May 15, 2006. The feedback from this FDA meeting will help the Company determine plans in moving forward.
The FDA Approvable Letter for indiplon 5 mg and 10 mg capsules requested that the Company reanalyze data from certain preclinical and clinical studies to support approval of indiplon capsules for sleep initiation and middle of the night dosing. The FDA also requested reexamination of the safety analysis for the elderly population. The FDA may require additional clinical and/or pre-clinical safety data.
The FDA Not Approvable Letter for indiplon 15 mg tablets requested that the Company reanalyze certain safety and efficacy data. The letter also questioned the sufficiency of the Company's objective sleep maintenance clinical data with the 15 mg tablet in view of the fact that the majority of the Company's indiplon tablet studies were conducted with doses higher than 15 mg. Additional clinical data will likely be required.
The Company believes that information it included in the submissions and subsequent amendments submitted during the review period have provided responses to a number of the issues raised by the FDA in the action letters. These amendments include reanalysis of certain data for indiplon capsules and a polysomnographic clinical study with indiplon 15 mg tablets.
"On May 17, we notified the FDA that we intend to further amend both applications to respond to the deficiencies raised by the FDA. Our immediate focus is to meet with the FDA to determine the nature and scope of any additional preclinical and/or clinical work the agency may require for approval," said Gary Lyons, President and Chief Executive Officer. "We will make final plans for the NDA resubmissions once we have clarified this in conference with the FDA. We are also expecting to amend financial guidance in our second quarter financial webcast."
Source: Neurocrine Biosciences, Inc.
Posted: June 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 Reports Results of FDA End-of-Review Meeting on Indiplon Capsules NDA - September 5, 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