Abstracts
3427202
(#45) Real-World Clinical Outcomes of Patients Switching to Treatment With Dextromethorphan-Bupropion (45 mg/105 mg)
Abstract: Introduction: Dextromethorphan-bupropion (45/105 mg; Auvelity®), an oral NMDA receptor antagonist and sigma-1 agonist, is approved in the US for adults with MDD. This study evaluated real-world clinical outcomes of patients initiating dextromethorphan-bupropion.
Methods: Adults initiating dextromethorphan-bupropion were identified in US electronic health record (EHR) data (August 2022-March 2025). Outcomes including the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 2-item (GAD-2), and CGI-Improvement (CGI-I) scales, as well as body weight, were evaluated using pairwise comparisons between first prescription and follow-up timepoints.
Results: Among 217 patients (58% female; mean age: 43 years), comorbid anxiety (88.5%) and ADHD (79.3%) were common; 86.6% had prior MDD-related treatments (most recent: SSRIs 35.0%, NDRIs 19.4%, SNRIs 18.4%, antipsychotics 14.3%, esketamine 5.5%). Dextromethorphan-bupropion was initiated as monotherapy in 71.9%. Baseline mean PHQ-9 was 11.48; 58.0% were moderate-to-severe. Improvements in all outcomes were observed by Week 1 and were significant at Week 2, Week 6, and Month 3 (P 0.05), including GAD-2, PHQ-9, and anhedonia, as measured by PHQ-9 Item 1. CGI-I indicated improvement in 78.0%, 82.5%, and 83.9% at Week 2, Week 6, and Month 3, respectively. Body weight remained stable throughout the evaluation period.
Conclusions: In this retrospective EHR analysis, adult patients switching to dextromethorphan-bupropion demonstrated rapid and lasting improvements in both patient- and clinician-rated outcomes over 3 months. Most patients had mental-health related comorbidities and attempted various MDD-related treatments; 80% initiated dextromethorphan-bupropion as a monotherapy.
Short Description: Dextromethorphan-bupropion (45mg/105mg; Auvelity®) is approved for adults with MDD; this study evaluated real-world outcomes following initiation. US EHR data (2022-2025) identified adults starting treatment, with longitudinal assessment of PHQ-9, GAD-2, CGI-I, and body weight. Among 217 patients, improvements in symptoms of depression, anxiety, and anhedonia emerged by Week 1 and were significant by Week 2 through Month 3. Most patients exhibited improvement on CGI-I and stable body weight.
Name of Sponsoring Organization(s): Axsome Therapeutics, Inc.
Methods: Adults initiating dextromethorphan-bupropion were identified in US electronic health record (EHR) data (August 2022-March 2025). Outcomes including the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 2-item (GAD-2), and CGI-Improvement (CGI-I) scales, as well as body weight, were evaluated using pairwise comparisons between first prescription and follow-up timepoints.
Results: Among 217 patients (58% female; mean age: 43 years), comorbid anxiety (88.5%) and ADHD (79.3%) were common; 86.6% had prior MDD-related treatments (most recent: SSRIs 35.0%, NDRIs 19.4%, SNRIs 18.4%, antipsychotics 14.3%, esketamine 5.5%). Dextromethorphan-bupropion was initiated as monotherapy in 71.9%. Baseline mean PHQ-9 was 11.48; 58.0% were moderate-to-severe. Improvements in all outcomes were observed by Week 1 and were significant at Week 2, Week 6, and Month 3 (P 0.05), including GAD-2, PHQ-9, and anhedonia, as measured by PHQ-9 Item 1. CGI-I indicated improvement in 78.0%, 82.5%, and 83.9% at Week 2, Week 6, and Month 3, respectively. Body weight remained stable throughout the evaluation period.
Conclusions: In this retrospective EHR analysis, adult patients switching to dextromethorphan-bupropion demonstrated rapid and lasting improvements in both patient- and clinician-rated outcomes over 3 months. Most patients had mental-health related comorbidities and attempted various MDD-related treatments; 80% initiated dextromethorphan-bupropion as a monotherapy.
Short Description: Dextromethorphan-bupropion (45mg/105mg; Auvelity®) is approved for adults with MDD; this study evaluated real-world outcomes following initiation. US EHR data (2022-2025) identified adults starting treatment, with longitudinal assessment of PHQ-9, GAD-2, CGI-I, and body weight. Among 217 patients, improvements in symptoms of depression, anxiety, and anhedonia emerged by Week 1 and were significant by Week 2 through Month 3. Most patients exhibited improvement on CGI-I and stable body weight.
Name of Sponsoring Organization(s): Axsome Therapeutics, Inc.
