FOR ADULTS WITH MDD,
SUBSTANTIAL SYMPTOM IMPROVEMENT^* THAT WORKS

FAST FAST

Rapid and substantial symptom improvement^1,2

Rapid as early as Week 1 vs placebo
Protocol-defined remission (MADRS total score ≤10) as early as Week 2 vs placebo

LASTS LASTS

Sustained and substantial symptom improvement^1,2

Sustained at Week 6 vs placebo (primary endpoint)
Protocol-defined response (≥50% improvement in MADRS total score from baseline) at Week 6 vs placebo

AUVELITY WORKS DIFFERENTLY
Only antidepressant that modulates both glutamatergic and monoaminergic pathways^1,3†

100^% of Medicare Part D
patients have coverage^4§

>70% of Medicare patients have no prior authorization requirement to receive coverage for AUVELITY

For LIS/dual-eligible (Medicare + Medicaid) beneficiaries, patients pay less than $13 per month(varies by state)

^*As measured by MADRS total score.

^†Based on Symphony Health data. Growth calculated as percentage change in new to brand prescriptions from Q1 2025 to Q1 2026. Includes all prescription data aggregated across all indications for both AUVELITY and other standalone antidepressants.

^‡The mechanism of action of AUVELITY in the treatment of MDD is unclear.^1,3

GEMINI Phase 3 Study Design¹

Primary Endpoint¹

LS mean change from baseline in MADRS total score at Week 6.

Key Secondary Endpoints¹

LS mean change in MADRS total score from baseline at Week 1
LS mean change in MADRS total score from baseline at Week 2
Percentage of patients achieving response (≥50% reduction in MADRS total score from baseline) at Week 6
Percentage of patients achieving remission (MADRS total score ≤10) at Week 2

Other Secondary Endpoints¹

Clinical Global Impression-Improvement (CGI-I)
Clinical Global Impression-Severity (CGI-S)
Quality of Life Enjoyment and Satisfaction Questionnaire‑Short Form (Q‑LES‑Q‑SF)
Sheehan Disability Scale (SDS)
Patient Global Impression of Improvement (PGI‑I)
Quick Inventory of Depressive Symptomatology‑Self‑Report (16 items) (QIDS‑SR‑16)

Efficacy Assessments

Efficacy assessments were performed at Weeks 1, 2, 3, 4, and 6 on the mITT population. The mITT population was defined as all randomized patients who took at least 1 dose of study drug and had at least 1 post-baseline assessment. Examination of demographic subgroups by age, sex, and race did not suggest differences on the primary endpoint.¹

Footnotes and Definitions

BID=twice a day; LS=least squares; MADRS=Montgomery-Åsberg Depression Rating Scale; mITT=modified intention-to-treat.

Reference

losifescu DV, Jones A, O'Gorman C, et al. Efficacy and safety of AXS-05 (dextromethorphan-bupropion) in patients with major depressive disorder: a phase 3 randomized clinical trial (GEMINI). J Clin Psychiatry. 2022;83(4):21ml4345.

Patients with moderate to severe MDD were evaluated in the GEMINI trial^1,2

Not actual patients.

Demographic and baseline disease characteristics were generally similar across both treatment groups

~75% of patients were treatment-naïve during their current depressive episode (in GEMINI and ASCEND trials, n=397)³*

Footnotes and Definitions

AA=African American; BID=twice a day; BMI=body mass index; MADRS=Montgomery-Åsberg Depression Rating Scale; MDD=major depressive disorder; PHQ-9=Patient Health Questionnaire-9.

*Naïve=patients who have not been on another antidepressant treatment during their current depressive episode.³

References

losifescu DV, Jones A, O'Gorman C, et al. Efficacy and safety of AXS-05 (dextromethorphan-bupropion) in patients with major depressive disorder: a phase 3 randomized clinical trial (GEMINI). J Clin Psychiatry. 2022;83(4):21ml4345.
Hawley CJ, Gale TM, Smith PS, et al. Equations for converting scores between depression scales (MADRS, SRS, PHQ-9 and BDI-II): good statistical, but weak idiographic, validity. Hum Psychopharmacol. 2013;28:544-551.
Jones A, O'Gorman C, Clayton AH, Tabuteau H. Analysis of efficacy of AXS-05 in the treatment of major depressive disorder based on gender, race, and prior antidepressant use. Poster presented at: ISCTM Annual Meeting 2021; April 6–9, 2021.

Footnotes and Definitions

References

GEMINI Phase 3 Study Design1

Efficacy Assessments

Footnotes and Definitions

Reference

Patients with moderate to severe MDD were evaluated in the GEMINI trial1,2

~75% of patients were treatment-naïve during their current depressive episode (in GEMINI and ASCEND trials, n=397)3*

Footnotes and Definitions

References

GEMINI Phase 3 Study Design¹

Patients with moderate to severe MDD were evaluated in the GEMINI trial^1,2

~75% of patients were treatment-naïve during their current depressive episode (in GEMINI and ASCEND trials, n=397)³*