IndiplonTreatment for Insomnia
Neurocrine Announces Resubmission of New Drug Application for Indiplon Capsules
SAN DIEGO, June 12, 2007 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. announced today that they have resubmitted its New Drug Application (NDA) for indiplon 5 mg and 10 mg capsules for the treatment of insomnia in both adult and elderly patients to the U.S. Food and Drug Administration (FDA). The resubmission is a complete response to the FDA's May 15, 2006 approvable letter. The indiplon NDA resubmission is based on analyses discussed with statistical, clinical and regulatory consultants. In addition the Company has had interactions with the FDA regarding additional analyses of data previously submitted on indiplon capsules.
"We are pleased to announce the resubmission of the NDA for indiplon capsules and we look forward to working with the FDA in the review process of our resubmission," said Gary A. Lyons, President and CEO of Neurocrine Biosciences. "We believe that indiplon's unique profile can offer an effective solution for those patients who need help getting to sleep or returning to sleep after a nighttime awakening."
Indiplon is a non-narcotic non-benzodiazapine agent that acts on a specific site of the GABA-A receptor and potentiates the action of GABA. While other drugs also act on this receptor, indiplon's mechanism is unique in that it has been shown to bind more selectively to the specific subtype of GABA-A receptors within the brain believed to be responsible for promoting sleep. Indiplon was licensed from DOV Pharmaceutical in 1998.
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, endometriosis, irritable bowel syndrome, pain, and diabetes. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com
In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine's business and finances in general as well as, risk and uncertainties associated with the Company's indiplon program and planned commercialization activities, including but not limited to; risk that regulatory authorities may refuse to accept the filing of our resubmission of the indiplon capsule NDA; risk that regulatory authorities may find our resubmission of the indiplon capsule NDA incomplete or insufficient or otherwise unapprovable or that approval may be delayed; risk that following approval of indiplon capsules, commercialization may be delayed for any of a number of reasons including market conditions and product supply; risk that we will not be able to independently commercialize indiplon capsules or find a marketing partner on reasonable terms or at all; risk that the indiplon capsule labeling granted by regulatory authorities may limit the commercial success of indiplon capsules; and risk relating to market acceptance of indiplon capsules following marketing approval; in addition to the other risks described in the Company's report on Form 10-K for the year ended December 31, 2006 and Form 10-Q for the quarter ended March 31, 2007. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
CONTACT: Investor Contacts, Elizabeth Foster or Timothy Coughlin, both ofNeurocrine Biosciences, +1-858-617-7600
Web site: http://www.neurocrine.com/
Ticker Symbol: (NASDAQ-NMS:NBIX)
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Posted: June 2007
- Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA - December 13, 2007
- Neurocrine Announces PDUFA Action Date of December 12, 2007 for Indiplon Capsules - August 22, 2007
- Neurocrine Reports Results of FDA End-of-Review Meeting on Indiplon Capsules NDA - September 5, 2006
- Neurocrine Completes Review of Indiplon Action Letters - June 15, 2006
- Neurocrine Receives Approvable Letter for indiplon Capsules and Non-Approvable for indiplon Tablets for the Treatment of Insomnia - May 16, 2006
- Neurocrine Announces Acceptance of New Drug Application for Indiplon Tablets - July 26, 2005
- Neurocrine Announces Acceptance of New Drug Application for Indiplon Capsules - June 14, 2005
- Neurocrine Announces Submission of New Drug Application for Indiplon Tablets - May 26, 2005
- Neurocrine Announces Submission of New Drug Application for Indiplon Capsules - April 14, 2005
- Neurocrine Biosciences Announces Resubmission Status of Indiplon - February 7, 2005
- Neurocrine Biosciences Announces Plans to Resubmit Indiplon Modified Release New Drug Application (NDA) - January 11, 2005
- Indiplon IR NDA (New Drug Application) to Be Reformatted Due to Difficulties in Accessing Portions of the Electronic NDA - December 21, 2004
- Neurocrine Submits New Drug Application (NDA) for Indiplon Modified Release Tablets for the Treatment of Insomnia - November 22, 2004
- Neurocrine Submits New Drug Application (NDA) for Indiplon Immediate Release Capsules for the Treatment of Insomnia - October 19, 2004
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