Auvelity

Auvelity is indicated for the treatment of major depressive disorder (MDD) in adults. It follows a 505(b)(2) regulatory pathway and is not a controlled substance. The recommended starting dosage is one tablet once daily, increasing to one tablet twice daily after 3 days, with a maximum daily dose of two doses. Each tablet contains 45 mg of Dextromethorphan and 105 mg of Bupropion.

Efficacy was assessed using the MADRS total score change from baseline. Auvelity demonstrated statistically superior improvement in MADRS total score change from baseline to Week 6 compared to placebo. The MADRS total score change from baseline to end of treatment was statistically significantly superior to placebo. LS mean differences in MADRS total score change from baseline versus placebo ranged from 2.23 to 3.87. In one study, the AXS-05 group showed an 11.43 points reduction in MADRS total score, while the Bupropion group showed a 9.71 points reduction (p=0.117).

Safety findings include a Boxed Warning for Suicidal Thoughts and Behaviors. Adverse reactions with an incidence of >=5% and twice as frequent as placebo included dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis. Discontinuation due to adverse events was observed in 9 subjects overall, with 6 in the AXS-05 group and 3 in the Bupropion group. A total of 1114 subjects were exposed to AXS-05 in 6-week controlled trials, and 1606 subjects were exposed across all clinical trials. 597 subjects were treated for at least 6 months, and 110 subjects for at least 12 months.