Auvelity trials?

Auvelity (dextromethorphan-quinidine) has two main pivotal Phase 3 trials in major depressive disorder.

What the trials looked at
- Trials: GEMINI-1 and GEMINI-2 (randomized, double-blind, placebo-controlled, multicenter Phase 3)
- Population: adults with major depressive disorder who had an inadequate response to 1–3 prior antidepressants
- Design: fixed-dose combination of dextromethorphan and quinidine (the quinidine inhibits metabolism of dextromethorphan to allow its activity); compared against placebo
- Duration: typically 6 weeks
- Primary endpoint: change from baseline in MADRS (Montgomery–Åsberg Depression Rating Scale) total score at Week 6
- Secondary endpoints: response rate (e.g., proportion achieving ≥50% MADRS reduction), remission rates, and other clinical scales

Key results (highlights)
- Auvelity showed statistically significant improvement vs placebo on the primary endpoint (MADRS change) at Week 6 in both trials.
- Some analyses suggested an earlier onset of effect compared with placebo, with improvements observable within the first weeks.
- Secondary outcomes generally favored Auvelity vs placebo (higher response/remission rates in several analyses).
- Safety signals were comparable to expectations for this class; the most common adverse events included dizziness, nausea, constipation, and somnolence.

Safety and important considerations
- Boxed warning: suicidality in young adults and adults with major depressive disorder
- Dextromethorphan-quinidine can interact with serotonergic agents (SSRI/SNRI/MAOI) and other drugs; risk of serotonin syndrome with certain combinations
- Quinidine is a potent CYP2D6 inhibitor; potential for drug–drug interactions
- Other safety notes: risk of dizziness, sedation, blood pressure changes, QT prolongation risk (due to quinidine), and rare psychiatric or cognitive effects
- Not suitable for everyone; use requires clinician oversight, especially in patients with heart rhythm issues or many drug interactions

If you want more details
- I can pull precise numbers (MADRS difference, p-values, response/remission rates) from the GEMINI trials or the FDA label
- I can summarize the official FDA labeling for dosing, safety warnings, and contraindications
- I can point you to the primary publications or FDA briefing documents

Would you like me to fetch specific data (e.g., exact MADRS changes, percent responders, or the FDA label references)?