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IndiplonIindiplon is a unique non-narcotic, non-benzodiazepine 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.
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Indiplon is in the developement stage and is not yet available.
INDIPLON DRUG INFO
IMPORTANT NOTE: INDIPLON is still in the developement stage. The information below is provided for information purposes only. For more information regarding Indiplon or Neurocrine Biosciences, Inc. please visit Neurocrine Biosciences.
Neurocrine Biosciences Press Release 09/05/2006
Neurocrine Reports Results of FDA End-of-Review Meeting on Indiplon Capsules NDA
SAN DIEGO, September 5, 2006 -- Neurocrine Biosciences, Inc. today reported the results of its end-of-review meeting with the Food and Drug Administration (FDA) meeting for the indiplon capsules New Drug Application (NDA). The meeting with the FDA was specifically focused on determining the actions needed to bring indiplon immediate-release (IR) capsules from Approvable to Approval for the treatment of insomnia.
The Company summarized the results of the FDA meeting as follows:
The FDA requested that the Company supplement the pharmacokinetic/food effect profile of indiplon (IR) capsules to include several meal types.
The Company will initiate such a study shortly after further consultation with the FDA. No other clinical trials were requested for the re-submission;
The re-submission will also include further analyses and modifications of analyses previously submitted which address questions raised by the agency in the initial review.
"We are pleased to have clarified the outstanding issues with the FDA and expect to resolve the remaining issue in the coming weeks," said Gary A. Lyons, President and Chief Executive Officer of Neurocrine Biosciences. "Subject to those further consultations with the FDA we are expecting to provide a complete re-submission sometime before the end of the 2nd Qtr 2007. We are encouraged about the prospects for indiplon capsules to compete effectively in the marketplace upon approval and continue to evaluate alternatives for bringing it to market in a timely manner."
Separately, the Company has also confirmed that its request for an end-of- review meeting with the FDA to discuss and clarify action items for indiplon (MR) tablets has been scheduled towards late October 2006.
Neurocrine Biosciences Press Release 10/19/2004
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. tramadol
"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.
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, 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.
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