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Author: Admin | 2025-04-28
From Wikipedia, the free encyclopedia Dextromethorphan/bupropionDextromethorphanBupropionCombination ofDextromethorphanNMDA receptor antagonist, σ1 receptor agonist, serotonin-norepinephrine reuptake inhibitor, nicotinic acetylcholine receptor negative allosteric modulator, and other actionsBupropionNorepinephrine–dopamine reuptake inhibitor and nicotinic acetylcholine receptor negative allosteric modulatorClinical dataTrade namesAuvelityOther namesDXM/BUP; AXS-05License dataUS DailyMed: Dextromethorphan and bupropionRoutes ofadministrationBy mouthATC codeN06AX62 (WHO) Legal statusLegal statusUS: ℞-only[1]IdentifiersCAS Number2360540-77-6KEGGD12493Dextromethorphan/bupropion (DXM/BUP), sold under the brand name Auvelity, is a combination medication for the treatment of major depressive disorder (MDD).[1] Its active components are dextromethorphan (DXM) and bupropion.[1] Patients who stayed on the medication had an average of 11% greater reduction in depressive symptoms than placebo in an FDA approval trial.[2][3] It is taken as a tablet by mouth.[1]Side effects of dextromethorphan/bupropion include dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis, among others.[1] The mechanism of action of dextromethorphan/bupropion in the treatment of depression is unknown.[1]Dextromethorphan/bupropion was developed by Axsome Therapeutics and was approved for the treatment of major depressive disorder in the United States in August 2022.[1]Antidepressant efficacy of dextromethorphan/bupropion (Auvelity) versus placebo in the GEMINI clinical trial.[1][3][4][5] The scores shown are the mean total depression scores on the MADRS over 6 weeks. Only 124/156 patients completed 6 weeks of Auvelity while 150/162 patients completed 6 weeks of placebo, consistent with a high rate of adverse reactions.[4][5][2]Dextromethorphan/bupropion is approved for the treatment of major depressive disorder.[1] Dextromethorphan and bupropion have both individually been reported to be effective for the treatment of this condition.[6][7][8] The effect size of bupropion alone relative to placebo for depression is small,[7][8] whereas only limited evidence exists for dextromethorphan alone.[6] The combination was approved in the US on the basis of two regulatory clinical trials.[1]In Study 1 (GEMINI), a 6-week randomized controlled trial of dextromethorphan/bupropion versus placebo in people with major depressive disorder, scores on the Montgomery–Åsberg Depression Rating Scale (MADRS)—a scale with a range of 0 to 60 points—decreased with dextromethorphan/bupropion by 15.9 points from a baseline score of 33.6 points (an approximate 47% reduction) and decreased with placebo by 12.1 points from a baseline score of 33.2 points (an approximate 36% reduction).[1][3] This resulted in a least-squares mean difference in reduction of depression scores between dextromethorphan/bupropion and placebo of 3.9 points, with the placebo group showing approximately 76% of the improvement in depression scores as the dextromethorphan/bupropion group and with depression scores at baseline improving overall about 11% more with the medication than with placebo.[1][3] In antidepressant trials of 6 to 8 weeks duration recorded in the Food and Drug Administration (FDA) database, the average difference from placebo with other antidepressants was 2.5 points.[3] The mean improvement in scores with dextromethorphan/bupropion was statistically significant but not clinically significant[9] relative to placebo at all assessed timepoints including at the end of week
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