GEMINI Phase III trial of AXS 05 shows improved outcomes in depression.- Axsome Therapeutics

The GEMINI study was a randomized, double-blind, placebo-controlled, multi-center, U.S. trial, in which 327 adult patients with confirmed moderate to severe MDD were randomized to treatment with either AXS 05 (dextromethorphan/bupropion modulated delivery tablet) or placebo once daily for the first 3 days and twice daily thereafter for a total of 6 weeks. Two patient-reported outcomes (PROs) for depression were assessed in this trial: the Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR-16), and the Patient Global Impression of Improvement (PGI-I) for depression. The PROs complement the clinician-rated measures, such as the Montgomery-Åsberg Depression Rating Scale (MADRS), that were also assessed in the GEMINI trial. AXS 05 demonstrated a highly statistically significant reduction in patient-reported depressive symptoms compared to placebo at Week 6, with mean reductions from baseline in the QIDS-SR-16 total score of 7.8 points for AXS 05 and 5.4 points for placebo, representing 48% and 34% reductions from baseline, respectively (p=0.001). AXS 05 rapidly and durably improved patient-reported depressive symptoms as compared to placebo with statistical significance on the QIDS-SR-16 total score demonstrated at Week 1 (p=0.016), the earliest time point assessed, at Week 2 (p<0.001), and at all time points thereafter. clinical response on the qids-sr-16 (defined as at least 50% improvement) was statistically significantly greater for axs 05 compared to placebo at week 1 (p="0.048)," at week 2 (p><0.001), and at every time point thereafter, being achieved by 53.4% of axs 05 patients compared to 32.9% of placebo patients at week 6 (p><0.001). on the patient-reported global measure of depression, the pgi-i, axs 05 demonstrated highly statistically significant improvements as compared to placebo, with 47.2% of patients treated with axs 05 reporting that their depression was “very much” or “much” improved compared to 31.3% of placebo patients at week 6 (p="0.007)." improvement on the pgi-i with axs 05 as compared to placebo was rapid and durable with statistical significance demonstrated at week 1 (p="0.008)" and at all time points thereafter. the results on these patient-reported measures are consistent with those observed with the corresponding clinician-rated scales, the madrs and the clinical global impression of improvement (cgi-i). as previously reported, axs 05 met the primary endpoint in the gemini trial by demonstrating a highly statistically significant reduction in the madrs total score compared to placebo at week 6, with mean reductions from baseline of 16.6 points for axs 05 and 11.9 points for placebo (p="0.002)." axs 05 also demonstrated statistically significant improvement at week 6 compared to placebo on the cgi-i (p="0.016)." rapid improvement in depressive symptoms was also demonstrated on these clinician-rated scales, with statistically significant improvements starting at week 1 and every timepoint thereafter (madrs p="0.007," cgi-i p="0.035)." axs-05 was well tolerated in the trial. these findings were presented at the 33rd congress of the european college of neuropsychopharmacology (ecnp), being held virtually september 12-15.></0.001).></0.001),></0.001),>