Axsome Publishes Results of AXS-05 (dextromethorphan-bupropion) in P-III (GEMINI) Trial for Major Depressive Disorder in The Journal of Clinical Psychiatry
Shots:
- The P-III (GEMINI) trial evaluates AXS-05 (45mg dextromethorphan/105mg bupropion tablet) vs PBO in 327 patients with MDD
- The results showed a rapid, substantial & significant improvement in depressive symptoms & induction of remission, change from baseline in MADRS score to 6wk. was greater with AXS-05, remission rates (39.5% vs 17.3%) @2wks. The majority of secondary outcomes favored AXS-05 while other 2EPs were better with AXS-05 at all timepoints & were well tolerated
- AXS-05 is an oral, patent-protected, NMDA receptor antagonist with a multimodal activity for MDD & other CNS disorders. The therapy has received BTD from the US FDA for MDD & ADD agitation. AXS-05’ NDA is under the US FDA’s review for MDD
Ref: PRNewswire | Image: Axsome
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