IndiplonTreatment for Insomnia
Neurocrine Submits New Drug Application (NDA) for Indiplon Immediate Release Capsules for the Treatment of Insomnia
SAN DIEGO, October 19, 2004 -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for regulatory approval of indiplon immediate release capsules for the treatment of insomnia. The application contains safety and efficacy results from seven Phase III clinical trials with indiplon immediate release conducted in adult and elderly patients with transient and chronic insomnia. Neurocrine is developing two formulations of indiplon, an immediate release capsule and modified release tablet, for the treatment of multiple forms of insomnia. Neurocrine expects to submit a second NDA for indiplon modified release tablets in November. This first NDA submission contains non-clinical, clinical and manufacturing information that is common to both applications.
The NDA has been submitted in electronic common technical document format (e-CTD). It includes data from a comprehensive safety and efficacy evaluation in approximately 3000 subjects.
"Insomnia affects over 85 million younger and older adults every year and is becoming more recognized by physicians as a disease that affects many aspects of patients' health and well-being. Insomnia is not a one size fits all condition as patients experience various types of sleep difficulties and symptoms such as trouble falling asleep, trouble staying asleep or waking up frequently during the night. Indiplon capsules and tablets have consistently demonstrated robust efficacy and safety in repeated clinical evaluations, measuring multiple parameters of sleep difficulties. These results confirm that indiplon will offer physicians a significant improvement in the diagnosis and treatment of patients' individual sleep needs," said Dr. Thomas Roth, Director Sleep Disorders Center, Henry Ford Hospital.
"The submission of the indiplon NDA is a significant milestone for Neurocrine, the first in the Company's history. Indiplon is an important advancement in the treatment of insomnia as it was specifically designed and developed to address the individual sleep needs of patients. Indiplon capsules have consistently demonstrated that patients fall asleep faster, have improved sleep quality and sleep duration. Phase III safety and efficacy clinical trials have shown that indiplon capsules can be taken during the night for patients who suffer from nighttime awakenings and have been shown to be safe and effective for long term chronic usage. We are pleased to have Pfizer, the leading global pharmaceutical company, as our partner in the development and commercialization of indiplon," said Gary A. Lyons, President and CEO of Neurocrine Biosciences.
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. Two formulations of indiplon, immediate release capsules and modified release tablets, are being evaluated in clinical trials to address different types of sleep problems. Indiplon was licensed from DOV Pharmaceutical in 1998.
Insomnia is a prevalent condition in the United States, with approximately 40 percent of the adult population reporting trouble sleeping a few nights per week or more, according to the National Sleep Foundation's (NSF) Sleep in America Poll 2002. Approximately 35 percent of the adult population reports that they have experienced insomnia every night or almost every night within the past year. Insomnia remains a disorder with high unmet medical needs, including prolonged awakenings during the night with difficulty falling back to 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 via the Internet at www.neurocrine.com.
Posted: October 2004
- 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 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