Shots:
The P-II (ASCEND) study evaluate AXS-05 (45mg dextromethorphan/105mg bupropion) vs bupropion (105mg, BID for 6wks.) in a ratio (1:1) in 80 patients with MDD
The trial met prespecified 1EPs i.e., mean reduction from baseline in MADRS total score (17.2 vs 12.1 points) @6wk., (47% vs 16%) improvement in depressive symptoms demonstrated the superiority over bupropion @1st wk., an improvement on CGI-I @1wk. & (59% vs 27%) @6wk. along with improvement on multiple 2EPs including remission (47% vs 16%), was safe & well-tolerated with similar rates of AEs
Additionally, 51% had experienced ≥3 MDE & 23% had received 1L treatment in MDE. The results from the P-III trial of AXS-05 are expected in Q2’22
Ref: Globenewswire | Image: Axsome
