Neurocrine Biosciences, Inc. has reported the results of its end-of-review meeting with the Food and Drug Administration (FDA) meeting for the indiplon capsules New Drug Application (NDA). The meeting with the FDA was specifically focused on determining the actions needed to bring indiplon immediate-release (IR) capsules from approvable to approval for the treatment of insomnia.
The company summarized the results of the FDA meeting as follows: The FDA requested that the company supplement the pharmacokinetic food effect profile of indiplon (IR) capsules to include several meal types. The company will initiate such a study shortly after further consultation with the FDA. No other clinical trials were requested for the re-submission.
The re-submission will also include further analyses and modifications of analyses previously submitted which address questions raised by the agency in the initial review.
"We are pleased to have clarified the outstanding issues with the FDA and expect to resolve the remaining issue in the coming weeks," said Gary A. Lyons, President and CEO of Neurocrine Biosciences. "Subject to those further consultations with the FDA we are expecting to provide a complete re-submission sometime before the end of the 2nd Qtr 2007. We are encouraged about the prospects for indiplon capsules to compete effectively in the marketplace upon approval and continue to evaluate alternatives for bringing it to market in a timely manner."
Separately, the company has also confirmed that its request for an end-of- review meeting with the FDA to discuss and clarify action items for indiplon tablets has been scheduled towards late October 2006.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. The product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, and autoimmunity.