Real-World AXS-05 Patient Characteristics in Major Depressive Disorder

Abstract: Introduction: AXS-05 (dextromethorphan-bupropion), a novel, oral, N-methyl-D-aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist, gained approval from the US FDA in August 2022 for treating major depressive disorder (MDD) in adults. Methods: Using Symphony IDV® databases until September 2023, adult patients initiating AXS-05 were identified (Index date: the first claim). All patients had continuous eligibility over the 12-month pre-index period and at least one MDD diagnosis over the 5-year pre-index period. Patient demographics and clinical characteristics over the 12-month pre-index period and AXS-05 initiation status were examined. Results: Among 22,288 MDD patients treated with AXS-05, most (58.5%) had commercial insurance, followed by Medicaid (17.9%) and Medicare (15.4%). Common comorbidities included mental health disorders (53.5%; 47.6% had anxiety disorders), metabolic (26.4%), musculoskeletal/pain (22.6%), cardiovascular disorders (19.0%), and sleep disorders (18.4%). The last pre-AXS-05 treatment comprised 22.4% SSRI, 13.2% SNRI, and 12.8% NDRI (bupropion only) monotherapies; 294 (1.3%) patients were on esketamine. Overall, 83.7% of patients received SSRIs/SNRIs/NDRIs over the 12-month pre-index period (SSRI: 54.9%, NDRI: 40.4%, SNRI: 35.9%); 2.9% of patients utilized esketamine. Altogether, 28.8% initiated AXS-05 as monotherapy vs 71.2% as an add-on; most commonly with an SSRI alone (10.7%) or SNRI alone (6.5%). Notably, 10.1% initiated AXS-05 without prior treatment in the 12-month pre-index period. Conclusions: Within a year of its approval, over 22,000 MDD patients initiated AXS-05, with 10.1% of patients being treatment-naïve during the 12-month pre-index period and 28.8% initiating AXS-05 as monotherapy. Most patients had mental health related comorbidities and attempted MDD-related treatments before AXS-05 initiation.Short Description: Patients with major depressive disorder (MDD) are heterogenous in nature and treatment can vary based on differences in MDD presentation, patient characteristics, health insurance coverage, and physician preferences for antidepressant treatment (ADT). It is common for many patients to not adequately respond to initial ADTs. To gain insights into the characteristics of patients and treatment patterns, we analyzed real-world data of individuals diagnosed with MDD who were prescribed AXS-05 since its approval in August 2022.Name of Sponsoring Organization(s): Axsome Therapeutics