FDA Expedites Sage Therapeutics’ SAGE-217 Treatment For Major Depressive Disorder

On June 12, 2018, Sage Therapeutics announced an expedited development plan for SAGE-217 as a treatment for major depressive disorder (MDD) and postpartum depression (PPD), to support the Breakthrough Therapy designation granted by the U.S. Food and Drug Administration (FDA) in February 2018. Sage plans to initiate a placebo-controlled Phase 3 trial in MDD during the second half of 2018. Sage also anticipates announcing top-line data from the placebo-controlled pivotal trial of SAGE-217 in PPD in the fourth quarter of 2018. Sage intends to file for full FDA approval for SAGE-217 as treatment . . .