Neurocrine Biosciences (NBIX) Message Board

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Neurocrine Biosciences (NBIX)

NBIX 143.25

+0.9%

Nov 4 3:59 PM EST

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

From: Icebrg	12/13/2007 3:35:10 AM
	of 1834

Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA Thursday December 13, 3:00 am ET SAN DIEGO, Dec. 13 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - News) announced today that the Company has received communication from the U.S. Food and Drug Administration (FDA) indicating that the New Drug Application (NDA) for indiplon 5 mg and 10 mg capsules for the treatment of insomnia is approvable pending additional clinical and preclinical data. On May 15, 2006, the Company received an action letter from the FDA stating that indiplon 5 mg and 10 mg capsules were approvable (2006 Approvable Letter). The 2006 Approvable Letter requested that the company reanalyze data from certain preclinical and clinical studies to support approval of indiplon 5 mg and 10 mg capsules for sleep initiation and middle of the night dosing. The 2006 Approvable Letter also requested reexamination of the safety analyses. At the August 2006 end-of-review meeting where the 2006 Approvable Letter was discussed, the FDA requested that the resubmission include further analyses and modifications of analyses previously submitted to address questions raised by the FDA in the initial review. This reanalysis was completed and was resubmitted on June 12, 2007. On December 12, 2007, we received an action letter from the FDA stating that indiplon 5mg and 10mg capsules are Approvable (2007 Approvable Letter). The 2007 Approvable Letter did not raise any of the issues previously raised by FDA in the 2006 Approvable Letter. The requirements as spelled out in the 2007 Approvable Letter raised requirements as follows: -- An objective/subjective clinical trial in the elderly. -- A safety study assessing the rates of adverse events occurring with indiplon when compared to a marketed product. -- A preclinical study to evaluate indiplon administration during the third trimester of pregnancy. "While we are disappointed in the FDA action, we will accept the FDA's offer to discuss the applications via a meeting or telephone conference in order to clarify and determine the next steps required," said Gary A. Lyons, President and CEO of Neurocrine.

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next