CNS Spectrums
April 1, 2023
Amanda Jones, Roger S. McIntyre, Mark Jacobsen et al.
AXS-05 (dextromethorphan-bupropion) rapidly and significantly reduced anhedonic symptoms in adults with major depressive disorder. In a 6-week randomized, double-blind, placebo-controlled trial with 327 participants, those receiving AXS-05 showed a mean reduction of 4.44 points on the MADRS anhedonia subscale at Week 1 versus 2.69 points for placebo, and a reduction of 9.70 points at Week 6 versus 7.22 for placebo. Response rates were significantly greater for AXS-05 from Week 1 onward. Common adverse events included dizziness, nausea, and headache.
CNS Spectrums
April 1, 2023
Amanda Jones, Caroline Streicher, Shawn Alter et al.
In patients with major depressive disorder who had not improved after one prior antidepressant in the current episode, treatment with AXS-05 (dextromethorphan HBr 45 mg-bupropion HCl 105 mg) led to rapid and sustained improvements in depression and functioning. Mean scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) dropped by 9.1 points at one week, 13.3 points at two weeks, and 20.4 points at six weeks. Remission (MADRS score of 10 or less) was achieved by 5.7% of patients at one week, 16.2% at two weeks, and 46.0% at six weeks. Improvements in functioning were seen starting at one week and were maintained at 12 months. Common side effects included COVID-19 infection, nausea, headache, dry mouth, insomnia, and dizziness.
CNS Spectrums
April 1, 2023
Amanda Jones, Caroline Streicher, Shawn Alter et al.
AXS-05 (dextromethorphan-bupropion) is an oral NMDA receptor antagonist being developed for major depressive disorder. In two double-blind, randomized, controlled 6-week trials, AXS-05 showed rapid antidepressant effects. In the placebo-controlled GEMINI trial (327 participants), AXS-05 was superior to placebo on depressive symptom improvement starting at Week 1, with greater improvement on the MADRS scale (7.3 vs. 4.9 points), higher response rates (15% vs. 7%), and by Week 2, higher remission rates (17% vs. 8%). In the ASCEND trial (80 participants) comparing AXS-05 to bupropion alone, AXS-05 was superior from Week 2 on MADRS improvement (12.5 vs. 7.8 points) and remission (26% vs. 3%). Common adverse events included dizziness, nausea, headache, diarrhea, somnolence, and dry mouth.