A phase 2 Smoking Cessation trial with AXS-05 was completed in April of 2019 by Axsome Therapeutics and sponsor Duke University here Phase 2 Smoking Cessation. From the Axsome press release following results, a quote by James Davis of Duke University and principal investigator of the phase 2 clinical trial had the following to say.
"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 design. Reduction in ad-lib smoking was selected as the primary endpoint in this trial, because it has been shown to correlate with smoking abstinence. I look forward to the continued evaluation of AXS-05 as a smoking cessation treatment."
Varenicline is also known under commercialization as Chantix. The drug was developed by Pfizer, and FDA approved in 2006, with patent extending to 2020. After 2020 generic companies can replicate the drug and sell it at much lower prices. The drug has produced annual revenues of around $1 billion for Pfizer, even though the safety profile has come under scrutiny from the FDA. The side effect profile for Chantix is below.
The most common side effects of CHANTIX include nausea (30%), sleep problems (trouble sleeping, vivid unusual strange dreams) constipation, gas, and/or vomiting.
The potential opportunity for Axsome Therapeutics with AXS-05, would be exhibiting similar efficacy as Chantix has in clinical trials, but with fewer side effects associated with treatment. Current chart below.
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