Sage Therapeutics Reports Results of SAGE-217 in P-III MOUNTAIN Study for Major Depressive Disorders
Sage Therapeutics’ Zulresso (brexanolone) Receives FDA’s Approval for Postpartum Depression (PPD)
Shots:
- The P-III MOUNTAIN study involves assessing of SAGE-217 (20/ 30mg) vs PBO in 581 patients with MDD
- The P-III MOUNTAIN study results: did not meet its 1EP i.e, reduction in 17-item HAM-D score @15days; SAGE-217 (30mg) showed mean reduction in HAM-D (12.6 vs 11.2); reduction in HAM-D@3, 8 &12days; safe & well tolerated. Patients showed significant improvement in previous studies i.e, (HAM-D>24)
- SAGE-217 (PO) is a neuroactive steroid (NAS) GABAA receptor positive allosteric modulator, being evaluated in 5 studies out of which two reported positive data in MDD and PPD
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