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Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Smoking Cessation
Demonstrated statistically significant reduction in daily smoking compared to active comparator (p=0.0016)Trial conducted in collaboration with Duke
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"Demonstrated statistically significant reduction in daily smoking compared to active comparator (p=0.0016)Trial conducted in collaboration with Duke UniversityNEW YORK, April 15, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Duke University has completed its topline analysis of the Phase 2 trial of AXS-05 for smoking cessation treatment. The analysis showed that AXS-05 met the prespecified primary endpoint and significantly reduced daily smoking as compared to the active comparator bupropion. The trial was conducted at the Duke Center for Smoking Cessation under a research collaboration between Axsome and Duke University. The Phase 2 study was a randomized, double-blind, active-controlled trial, in which 58 adult smokers were treated either with AXS-05 (45 mg dextromethorphan/105 mg bupropion), or the active comparator bupropion (105 mg), twice daily, and assessed over a 3-week period.Treatment with AXS-05 resulted in a 25% greater reduction in the average number of cigarettes smoked per day over the 3-week period, the prespecified primary endpoint, as compared to bupropion (average reductions of 8.49 and 6.79 cigarettes per day for AXS-05 and bupropion, respectively, p=0.0016). Consistent with this finding, a greater proportion of smokers receiving AXS-05 experienced a more than 50% reduction in expired carbon monoxide levels, a biochemical marker of smoking intensity, as compared to those treated with bupropion (52.0% for AXS-05 versus 30.4% for bupropion, p=0.15). In addition, subjects who took AXS-05 as prescribed on a given day smoked 1.0 fewer cigarette on the day of medication use (p=0.026) and 1.2 fewer cigarettes on the following day (p=0.008) as compared to those who missed one or both doses.\"The findings in this trial are notable because AXS-05 was compared to bupropion, an approved treatment for smoking cessation.\" said James Davis, MD, Medical Director of the Duke Center for Smoking Cessation, and principal investigator of the trial. \"The improvement of AXS-05 over bupropion observed in this trial is similar in magnitude to the improvement over placebo reported for the approved smoking cessation treatment varenicline in studies with a similar ...