Neurocrine to meet with FDA on Not Approvable Letter for indiplon

By Lisa Kerner

Charlotte, N.C., June 15 - Neurocrine Biosciences, Inc. said it has requested a meeting with the Food and Drug Administration to discuss issues raised in 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.

The Approvable Letter requests 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, as well as a reexamination of the safety analysis for the elderly population.

In the Not Approvable Letter for indiplon 15 mg tablets, the FDA requested that Neuroscience reanalyze certain safety and efficacy data and questioned the sufficiency of objective sleep maintenance clinical data.

"On May 17, we notified the FDA that we intend to further amend both applications to respond to the deficiencies raised by the FDA," president and chief executive officer Gary Lyons said in a company news release.

"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."

The company said it will determine plans for NDA resubmissions following its meeting with the FDA. Financial guidance for the second quarter is expected to amended, according to officials.

Neurocrine is a San Diego-based biopharmaceutical company focused on neurological and endocrine diseases and disorders.

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