Neurocrine supplies data to FDA showing impact of indiplon on driving

By Angela McDaniels

Seattle, Jan. 10 - Neurocrine Biosciences Inc. said it has submitted to the Food and Drug Administration the results from a 2005 study that investigated the effects of indiplon, the company's investigational insomnia drug, on driving.

The company has been in discussion with the FDA about the review and approval of indiplon, and the FDA requested the driving study results in December.

Based on feedback from the FDA, the company said it anticipates that labeling for the product will include data from the driving study, which showed no impairment in next-day driving performance.

The FDA has stated its intent to issue a combined package insert in lieu of individual package inserts for each indiplon IR (capsule) and indiplon MR (tablet) New Drug Application.

To complete review of the driving study and the combined package insert, the FDA moved the Prescription Drug User Fee Act dates for the indiplon IR and indiplon MR applications to May 15 and June 27, respectively. However, Neurocrine said the FDA has committed to an action by May 15 for both applications.

Finally, the Controlled Substances Staff of the FDA has completed its scheduling recommendation which will be submitted to the Drug Enforcement Agency.

Based on discussions with the Drug Enforcement Agency, the company said it believes this hand off will allow the agency to complete its scheduling process in parallel with the FDA review process.

Neurocrine said it is moving forward with full commercialization as planned.

"We have been pleased with the ongoing discussions with the FDA and the Drug Enforcement Agency's commitment to review both applications in an expeditious manner which will result in a single package insert. A combined package insert will benefit consumers and prescribing physicians by providing a single source of indiplon information," president and chief executive officer Gary Lyons said in a company news release.

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

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.