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Article: Neurocrine Biosciences Announces Positive Phase II Efficacy and Safety Results With NBI-34060 Modified Release (MR); First Efficacy Based Trial in MR Shows Improvement in Maintaining Sleep.
- Article from:
- PR Newswire
- Article date:
- January 18, 2002
CopyrightCOPYRIGHT 2002 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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SAN DIEGO -- Neurocrine Biosciences, Inc. today announced positive efficacy results with NBI-34060 Modified Release (MR) tablets in a Phase II study in 47 adult patients with primary (chronic) insomnia with sleep maintenance complaints. This study was a randomized, multi-center, double-blind, placebo-controlled, five-way crossover, dose-response study, in which four doses (20 mg, 30 mg, 35 mg, and 40 mg) of MR tablets were tested. The primary endpoint was Sleep Efficiency (SE), defined as Total Sleep Time divided by 8 hours, as measured objectively by polysomnography (PSG). NBI-34060-MR demonstrated a statistically significant improvement in SE relative to placebo at 30 ...