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Article: Neurocrine Reports Positive Phase III Efficacy and Safety Results With Indiplon Modified Release in Treating Elderly Patients.
- Article from:
- PR Newswire
- Article date:
- September 9, 2004
CopyrightCOPYRIGHT 2004 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Neurocrine Is on Track to File NDAs for Both Indiplon IR and MR
Neurocrine Biosciences, Inc. today announced positive efficacy and safety results from the Company's Phase III clinical trial with indiplon modified release 15 mg in 229 elderly patients with chronic insomnia. Neurocrine is on track to submit its two New Drug Applications (NDAs) for the immediate and modified release formulations of indiplon beginning in October 2004. The two NDAs will include data from Phase I, II and III clinical trials in over 7400 patients and subjects with over 300,000 patient exposures in one of the most comprehensive clinical programs in insomnia. To date the indiplon ...