IndiplonTreatment for Insomnia
Neurocrine Announces Acceptance of New Drug Application for Indiplon Capsules
SAN DIEGO, June 14, 2005 -- Neurocrine Biosciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for indiplon capsules for review for the treatment of insomnia in both adult and elderly patients.
Indiplon is a unique non-narcotic, non-benzodiazapine agent that acts on a specific site of the GABA-A receptor. Indiplon has been shown to bind selectively to the specific subtype of GABA-A receptors within the brain believed to be responsible for promoting sleep. Indiplon was developed to address different types of sleep problems. Indiplon was licensed from DOV Pharmaceutical in 1998.
Insomnia is a prevalent condition in the United States. According to the National Sleep Foundation's (NSF) Sleep in America Poll 2005 approximately half of America's adults report that they experienced at least one symptom of insomnia a few nights a week or more in the past year. Sleep loss has been found to impair the ability to perform tasks involving memory, learning, and logical reasoning, yet few people understand the importance of sufficient sleep.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our 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.
Neurocrine Biosciences, Inc. news releases are available through the Company's website.
Posted: June 2005
- 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 Announces Resubmission of New Drug Application for Indiplon Capsules - June 13, 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 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