AUVELITY provided MDD symptom improvement that was FAST & LASTS^1,2

WEEK 1

FAST

Rapid symptom
improvement as
early as Week 1
vs placebo^1,2

Minimal clinically important difference (MCID) was observed at all time points, including Week 1^5,6‡

Symptom improvement in MADRS total score vs placebo
and estimated PHQ-9 equivalents^1-4*^†‡

WEEK 6

LASTS

Sustained symptom improvement
at Week 6
vs placebo^1,2

PHQ-9 Conversion

GEMINI Phase 3 study evaluated AUVELITY vs placebo in 327 patients (n=163 AUVELITY and n=164 placebo) with MDD.²

P-values for Weeks 3 and 4 were not adjusted for multiplicity and are therefore not presented.²

Estimated PHQ-9 equivalent based on a published conversion model.⁶

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.

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.

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

Not actual patients.

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

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.

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.

AUVELITY provided MDD symptom improvement that was FAST & LASTS1,2

Symptom improvement in MADRS total score vs placebo and estimated PHQ-9 equivalents1-4*†‡

Footnotes and Definitions

References

GEMINI Phase 3 Study Design1

Efficacy Assessments

Footnotes and Definitions

References

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

Footnotes and Definitions

References

Symptom improvement in MADRS total score vs placebo and estimated PHQ-9 equivalents1-4*†‡

MADRS to PHQ-9 Scale estimated equivalents in AUVELITY-treated patients2-4​*

AUVELITY provided MDD symptom improvement that was FAST & LASTS^1,2

Symptom improvement in MADRS total score vs placebo
and estimated PHQ-9 equivalents^1-4*^†‡

GEMINI Phase 3 Study Design¹

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

Symptom improvement in MADRS total score vs placebo
and estimated PHQ-9 equivalents^1-4*^†‡

MADRS to PHQ-9 Scale estimated equivalents
in AUVELITY-treated patients^2-4*