Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Requi...( SAN DIEGO Dec. 13 /- Neurocrine B...)

SAN DIEGO, Dec. 13 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) 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
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