GEMINI Phase III trial of AXS 05 meets endpoint in major depressive disorder.- Axsome Therapeutics

Axsome Therapeutics announced that AXS 05 (bupropion + dextromethorphan) met the primary endpoint and rapidly and significantly improved symptoms of depression in the GEMINI Phase III trial in major depressive disorder (MDD). 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 or placebo once daily for the first 3 days and twice daily thereafter for a total of 6 weeks. AXS 05 met the primary endpoint by demonstrating a highly statistically significant reduction in the Montgomery-�sberg Depression Rating Scale (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 rapidly and durably improved depressive symptoms as compared to placebo with statistical significance on the MADRS total score demonstrated at Week 1, the earliest time point assessed, and at all time points thereafter. Rates of remission from depression (defined as MADRS up to 10) were statistically significantly greater for AXS 05 compared to placebo at Week 2 (p=0.013) and at every time point thereafter, being achieved by 39.5% of AXS 05 patients compared to 17.3% of placebo patients at Week 6 (p<0.001). axs 05 demonstrated rapid onset of action with statistically significant improvement as compared to placebo on numerous endpoints at week 1, or only 4 days after the start of twice daily dosing. statistically significant improvements at week 1 were observed for madrs total score (key secondary endpoint, p="0.007);" patient global impression-improvement (pgi-i) (p="0.008);" clinical global impression-severity (cgi-s) (p="0.013);" clinical global impression-improvement (cgi-i) (p="0.035);" quick inventory of depressive symptomatology-self-rated (qids-sr-16) (p="0.016);" quality of life enjoyment and satisfaction questionnaire-short form (q-les-q-sf) (p="0.031);" and other endpoints.>

On all secondary endpoints including the following, AXS 05 demonstrated statistically significant improvement at Week 6 compared to placebo, reflecting increasing treatment effects over time: clinical response on the MADRS total score (defined as greater than 50%) (p<0.001); pgi-i (p="0.007);" cgi-s (p="0.002);" cgi-i (p="0.016);" qids-sr-16 (p="0.001);" sheehan disability scale (sds) (p="0.002);" and q-les-q-sf (p="0.011)." axs 05 was well tolerated in the trial. the most commonly reported adverse events in the axs-05 arm were dizziness, nausea, headache, diarrhea, somnolence, and dry mouth.>