Axsome Therapeutics Presents New Data from the GEMINI Trial Demonstrating Efficacy of AXS-05 on Anhedonia in Patients with Major Depressive Disorder

AXS-05 rapidly and significantly improved anhedonic symptoms, measured by the MADRS anhedonia subscale, starting 1 week after treatment

Data being presented at the American Society of Clinical Psychopharmacology (ASCP) 2022 Annual Meeting

NEW YORK, June 02, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that treatment with AXS-05 (dextromethorphan-bupropion) rapidly and significantly reduced anhedonic symptoms in the GEMINI Phase 3 trial in major depressive disorder (MDD). These new data are being presented today at the American Society of Clinical Psychopharmacology (ASCP) 2022 Annual Meeting, being held in Scottsdale, Arizona and virtually.

“Anhedonia is a disabling, common, and persistent feature of depression that substantially impairs patient functioning,” said Roger McIntyre, MD, Professor of Psychiatry and Pharmacology, University of Toronto, Canada and Executive Director of the Brain and Cognition Discovery Foundation in Toronto, Canada. “These results with AXS-05 demonstrate rapid reductions in anhedonic symptoms, and are consistent with observed improvements in patient functioning and quality of life associated with treatment with AXS-05 in clinical trials.”

Anhedonia is an impaired capacity to experience or anticipate pleasure. It is present in up to 75% of individuals with MDD1 and is ranked among the most bothersome symptoms of depression. Anhedonia is associated with suboptimal antidepressant treatment response and poor functional outcomes2,3.

The GEMINI trial assessed the efficacy and safety of AXS-05 versus placebo in patients with MDD. A total of 327 patients with a confirmed diagnosis of moderate to severe MDD were randomized to receive AXS-05 (45 mg dextromethorphan/105 mg bupropion tablet) (n=163), or placebo (n=164), once daily for the first 3 days and twice daily thereafter, for a total of 6 weeks. The primary endpoint was the treatment effect on the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to week 6. In this secondary, post-hoc, analysis of the trial, improvements in anhedonic symptoms in MDD were assessed by the MADRS anhedonia subscale.

In the trial, AXS-05 demonstrated rapid, substantial, and statistically significant improvement in symptoms of anhedonia compared with placebo. The change from baseline to week 6 on the MADRS anhedonia subscale was significantly greater with AXS-05 than with placebo (-9.70 points vs. -7.22 points; p=0.001). The improvement was rapid with the change on the MADRS anhedonia subscale from baseline to week 1, the first timepoint assessed, being significantly greater with AXS-05 than with placebo (-4.44 points vs. -2.69 points; p