Dextromethorphan HBr-bupropion HCI (Auvelity) is developed by Axsome Therapeutics.
The US Food and Drug Administration (FDA) has approved dextromethorphan HBr-bupropion HCI (Auvelity) for the treatment of adult patients with major depressive disorder (MDD).
The treatment, developed by Axsome Therapeutics, represents the first and only rapid-acting oral medicine approved by the FDA for the treatment of MDD with labeling of statistically significant antidepressant efficacy compared to placebo beginning at 1 week.
The approval is based on clinical trials where the rapid antidepressant effects of the treatment were sustained at all subsequent timepoints. The trials involved more than 1100 patients with depression, including the GEMINI placebo-controlled study and the ASCEND study comparing Auvelity to bupropion sustained-release tablets.
In the GEMINI study, the treatment was statistically significantly superior to placebo in the improvement of depressive symptoms, measured by the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.
In the ASCEND study, the treatment was statistically significant to bupropion sustained-release tablets 105 mg twice daily.
“The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile,” Maurizio Fava, MD, Psychiatrist-In-Chief, Department of Psychiatry, Massachusetts General Hospital, Executive Director, Clinical Trials Network & Institute, Associate Dean for Clinical & Translational Research, and Slater Family Professor of Psychiatry, Harvard Medical School said in a statement. “Given the debilitating nature of depression, the efficacy of Auvelity observed at one week and sustained thereafter may have a significant impact on the current treatment paradigm for this condition.”