Axsome Therapeutics has reported positive results from the Phase III GEMINI clinical trial of AXS-05 in patients with major depressive disorder (MDD).

AXS-05 is an investigational, oral N-methyl-D-aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist being developed to treat central nervous system (CNS) disorders, including MDD.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The drug candidate consists of dextromethorphan and bupropion. It is thought to enable improved communication between brain cells and increase serotonin, noradrenaline and dopamine levels.

GEMINI is a randomised, double-blind, multi-centre, placebo-controlled study conducted to investigate a twice-daily dose of the drug candidate for six weeks in a total of 327 patients with moderate-to-severe MDD.

The primary endpoint was the change in the mean Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week six, compared to placebo.

AXS-05 met the primary endpoint with a statistically significant decrease in the MADRS total score. At week six, the mean decrease from baseline was 16.6 points with AXS-05 versus 11.9 points with placebo.

In addition, the drug candidate led to improvements in depressive symptoms, demonstrating statistical significance on the MADRS total score at week one, the key secondary endpoint.

Statistically significant improvements were also observed on all secondary endpoints at week six, including remission, disease severity, functional impairment and quality of life.

At week six, remission from depression was experienced by 39.5% of patients treated with AXS-05 compared to 17.3% on placebo.

The drug candidate was found to be well-tolerated, with the most common adverse events being nausea, dizziness, headache, somnlence, diarrhoea and a dry mouth. Rates of adverse events-related discontinuation were low across the study groups.

Axsome Therapeutics CEO Herriot Tabuteau said: “With GEMINI and the previously completed ASCEND study, the efficacy of AXS-05 in major depressive disorder has now been demonstrated in two positive well-controlled trials, enabling the filing of an NDA for AXS-05, which is anticipated in the coming year.”

In March this year, the US Food and Drug Administration (FDA) awarded breakthrough therapy designation for AXS-05 to treat MDD.