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ARTICLE | Clinical News

ADX-N05: Phase IIa data

June 17, 2013 7:00 AM UTC

A double-blind, placebo-controlled, crossover, U.S. Phase IIa trial in 33 patients with narcolepsy showed that once-daily ADX-N05 met the primary endpoint of increasing sleep latency from baseline to week 2 as measured by the MWT vs. placebo. Specifically, average sleep latency was 11.8 minutes longer in patients receiving ADX-N05 compared to placebo (p=0.0002). ADX-N05 also significantly improved patient-reported Epworth Sleepiness Scale scores compared to placebo at both weeks 1 and 2 (p<0.0001 and p=0.0002, respectively). ADX-N05 was generally well tolerated. Patients received placebo or once-daily 150 mg ADX-N05 for 7 days followed by once-daily 300 mg ADX-N05 for 7 days. Data were presented at the SLEEP 2013 meeting in Baltimore. ...