AXS-05, an investigational modulated-delivery tablet combining dextromethorphan and bupropion, significantly improved symptoms of depression in patients with major depressive disorder (MDD) in a recent phase 3 trial, announced developer Axsome Therapeutics Inc.
In the double-blind, multicenter GEMINI study, 327 adults with moderate-to-severe MDD were randomized to treatment with either AXS-05—an oral NMDA receptor antagonist with multimodal activity—or placebo once daily for the first 3 days, and twice daily afterward, for a total 6 weeks.
By demonstrating a significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared with placebo at week 6, AXS-05 succeeded in meeting the study’s primary endpoint. Mean MADRS total score reductions from baseline were 16.6 points with the drug and 11.9 points with placebo.
In the study, AXS-05 also demonstrated:
• statistically significant improvement in MADRS total score at week 1, and at all subsequent time points through week 6, compared with placebo;
• a depression remission rate of 39.5% at week 6 (compared with a 17.3% remission rate with placebo); and
• statistically significant improvement on all secondary endpoints at week 6, including remission, disease severity, functional impairment, and quality of life, compared with placebo.
“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 new drug application for AXS-05, which is anticipated in the coming year,” said Herriot Tabuteau, MD, chief executive officer of Axsome.