IndiplonTreatment for Insomnia
Neurocrine Announces Submission of New Drug Application for Indiplon Capsules
Promising New Treatment Option Shown to Improve Sleep Onset and Sleep Maintenance
SAN DIEGO, April 14, 2005 -- Neurocrine Biosciences, Inc. announced that they have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for indiplon capsules for the treatment of insomnia in both adult and elderly patients. The filing was resubmitted to the FDA solely to address formatting difficulties with the electronic common technical document (e-CTDformat), originally submitted in late 2004, and did not pertain to the content of the filing.
"Insomnia takes a significant toll on the physical well-being, and emotional health of sufferers. This submission marks a major milestone in our commitment to provide people with a safe and effective treatment option," said Gary A. Lyons, President and CEO of Neurocrine Biosciences. "We believe that indiplon is an important advancement in the treatment of insomnia because it can provide the flexibility to address the individual sleep needs of people with insomnia for short or longer-term use."
The NDA for indiplon tablets will also be resubmitted to the FDA in the second quarter to address similar formatting difficulties encountered with the e-CTD format originally submitted in late 2004. Data from a recently completed clinical trial demonstrating the safety and efficacy of indiplon 15 mg tablets in adult patients will be added to the submission.
The indiplon NDA filings will contain data from 72 clinical trials and include a comprehensive safety and efficacy evaluation in more than 7,500 subjects. Clinical trial results have shown that indiplon capsules and tablets help patients consistently fall asleep faster, increase the amount of time they sleep during the night, decrease number of nighttime awakenings and improve overall sleep quality over the course of short or long-term treatment without evidence of next day effects.
Indiplon is a unique 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. Upon approval, indiplon will be copromoted in the US with Pfizer.
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.
For more information, please visit www.neurocrine.com
Posted: April 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 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 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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