Dextromethorphan-bupropion safe and effective treatment for major depression: Study

The primary endpoint was set as the overall treatment effect on the Montgomery-Åsberg Depression Rating Scale (MADRS) score (average of the change from baseline for weeks 1–6). MADRS score was assessed in all randomized patients whose diagnosis and severity were confirmed by an independent assessor and who received at least one dose of study medication and had at least one postbaseline assessment.

Key findings of the trial include:

• MADRS score was significantly greater with dextromethorphan-bupropion than with bupropion (−13.7 points vs. −8.8 points).

• Remission rates were significantly greater with dextromethorphan-bupropion at week 2 and every time point thereafter (week 6: 46.5% vs. 16.2%).

• Response rates (≥50% decrease in MADRS score from baseline) at week 6, were 60.5% with dextromethorphan-bupropion and 40.5% with bupropion.

• Dextromethorphan-bupropion presented adverse events like dizziness, nausea, dry mouth, decreased appetite, and anxiety but it was not associated with psychotomimetic effects, weight gain, or sexual dysfunction.

The authors conclude that dextromethorphan-bupropion (AXS-05) has proved its efficiency in improving depressive symptoms in patients with major depression without any major adverse events.

Dextromethorphan-bupropion (AXS-05) has shown promising results as a future potential treatment for patients with major depressive disorder, the authors wrote.

Reference:

Tabuteau H, Jones A, Anderson A, Jacobson M, Iosifescu DV. Effect of AXS-05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized Double-Blind Controlled Trial. Am J Psychiatry. 2022 Jul;179(7):490-499. doi: 10.1176/appi.ajp.21080800. Epub 2022 May 18. PMID: 35582785.