Neurocrine Submits New Drug Application (NDA) for Indiplon Modified Release Tablets for the Treatment of InsomniaThe FDA is expected to decide whether to approve indiplon by May 15, 2006 Neurocrine anticipates that the proposed rule in the Federal Register for the DEA will soon place Indiplon into Schedule IV of the Controlled Substances Act (CSA). This proposed action will be based on a recommendation from the Acting Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and on an evaluation of the relevant data by DEA. Based on discussions with the DEA, the Company expects the DEA will complete its process in parallel with the FDA review. May 2005: Brandweek reports that Pfizer and partner Neurocrine Biosciences, San Diego, will launch Indiplon, probably with a different brand name, in 2006. Update: On April 14, 2005 Neurocrine announced that they finally resubmitted their New Drug Application (NDA) to the for indiplon. They first submitted in late 2004, but there were technical problems with the application. Also, they have since accumulated more clinical data to support their claims. There is no word from the company about when they expect Indiplon to be available for prescription to the public. The delays were obviously a disappointment and Neurocrine's stock price declined in the first part of 2005. ********************* Press Release from Neurocrine SAN DIEGO, Calif., Nov. 22, 2004/PRNewswire-FirstCall/ -- 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 modified release tablets for the treatment of insomnia. The application contains safety and efficacy results from 8 Phase III clinical trials with indiplon modified release conducted in adult and elderly patients with transient and chronic insomnia. The NDA for indiplon immediate release capsules was submitted to the FDA on October 18 of this year. This NDA submission contains manufacturing and clinical information specific to the modified release formulation. The first NDA submitted in October for indiplon immediate release included non-clinical, clinical, and manufacturing information that was common to both applications. The NDAs have been submitted in electronic common technical document format (e-CTD) and include data from a comprehensive safety and efficacy evaluation in over 7500 subjects. "Patients with insomnia experience a wide range of symptoms such as trouble falling asleep, trouble staying asleep, and waking up frequently during the night. However, no two patients are alike as symptoms vary from patient to patient. The two formulations of indiplon will be an important advance in allowing physicians to tailor treatment to help improve patients' individual insomnia symptoms and, as a result, sleep quality. Clinical trials consistently showed that patients fell sleep quickly and stayed asleep longer when modified release tablets were taken at bedtime," said Dr. Thomas Roth, Director Sleep Disorders Center, Henry Ford Hospital. "The submission of the two NDAs for indiplon represents a great achievement for Neurocrine that will turn the focus of the Company towards commercialization. We believe that indiplon will set a new standard in the way physicians treat and manage insomnia. We are now moving forward with our partner, Pfizer, in preparing for the commercialization of indiplon, while building and training the Neurocrine sales force to co-detail Zoloft(R) with Pfizer to psychiatrists," said Gary A. Lyons, President and CEO of Neurocrine Biosciences. About Indiplon 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, have been 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 problems of frequent night time awakenings and difficulty falling back to sleep, sometimes referred to as sleep fragmentation.
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"Sleep hath seized me wholly" (William Shakespeare – Cymebline)
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