Axsome Therapeutics, Inc. — Auvelity FDA Review (NDA215430, ORIG 1, 2022)
Axsome Therapeutics, Inc. · 2022 · FDA Review (openFDA) · company profile →
Report summary
The FDA multidisciplinary review recommends approval for Axsome Therapeutics' Auvelity (bupropion and dextromethorphan) for Major Depressive Disorder (MDD). The fixed-dose combination demonstrated effectiveness in two key trials (MDD-301 and MDD-201), showing superiority over placebo and bupropion in reducing MADRS scores. While the safety profile is generally well-characterized, concerns regarding comprehensive non-clinical studies (carcinogenicity, genotoxicity, reproductive toxicology) and some efficacy analysis discrepancies led to proposed post-marketing requirements. The drug has a low abuse potential, and common adverse events are mild to moderate. Labeling will include a boxed warning for suicidal thoughts and behaviors, and post-marketing studies are required for specific populations and long-term safety.
Key findings — cited to the page
| Age range of subjects | 18 to 65 years years | MDD-201 · p.83 |
| Randomization ratio | 1:1 | MDD-201 · p.85 |
| MADRS total score for moderate or greater severity | ≥25 | MDD-201 · p.82 |
| QIDS-SR-16 score for diagnosis confirmation | ≥13 | MDD-201 · p.82 |
| BMI range of subjects | 18 and 40 kg/m2 | MDD-201 · p.83 |
| ICH E1 Guideline recommended subjects for safety database (exposure for at least 1 year) | 100 subjects | AXS-05 · p.32 |
| Trial phase | Phase 2 | MDD-201 · United States · p.82 |
| Treatment duration | 6 weeks | MDD-201 · p.82 |
| ICH E1 Guideline recommended subjects for safety database (short-term exposure) | 1500 subjects | AXS-05 · p.32 |
| CGI-S score for moderate or greater severity | ≥4 | MDD-201 · p.82 |
| ICH E1 Guideline recommended subjects for safety database (exposure for at least 6 months) | 300 to 600 subjects | AXS-05 · p.32 |
| Primary efficacy endpoint | mean change from baseline to Week 6 in MADRS total score | MDD-201 · p.87 |
Source: Axsome Therapeutics, Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →