Axsome Therapeutics has enrolled the first patient in a Phase II clinical trial analysing the efficacy and safety of AXS-05 for the treatment of smoking cessation.
The randomised, double-blind, active-controlled trial is currently being carried out under research collaboration between Duke University in the US and Axsome Therapeutics at the Duke Center for Smoking Cessation.
Under the trial, around 60 smokers interested in quitting will be randomised in a 1:1 ratio to receive either AXS-05 or bupropion for a period of four weeks.
The trial’s primary endpoint includes the change in smoking intensity, which will be measured by the number of cigarettes smoked per day, salivary cotinine, and carbon monoxide breath testing.
Secondary endpoints of the trial are smoking abstinence – measured using a seven-day abstinence test – adherence to treatment, withdrawal symptoms, stress, anxiety, and depression.
Axsome has used its metabolic inhibition technology to develop AXS-05, a new, oral, fixed-dose combination of dextromethorphan and bupropion.
Both the dextromethorphan and bupropioncomponents are nicotinic acetylcholine receptor antagonists.
Before commencing the Phase II trial, AXS-05 was studied for smoking cessation on an animal research model at Duke University. The study showed the ability of AXS-05’s dextromethorphan component to reduce nicotine self-administration.
Axsome has also conducted human studies to demonstrate the increased dextromethorphan plasma concentrations with AXS-05, and the efficacy of the bupropion component of AXS-05 in smoking cessation.
Currently, around 40 million adults in the US are reportedly involved in smoking and around 70% said they want to quit.
Smoking is found to be the single largest cause of premature deaths across the globe, thereby representing approximately 20% of all deaths in developed countries.