Expected regulatory pathway for episodic treatment of major depression remains unchanged with plan for one new additional efficacy study
Pursuing two additional pathways with the goal of accelerating patient access to zuranolone while continuing development for the episodic treatment of depression
Plans to pursue novel development and filing pathway for acute, rapid treatment of major depressive episodes when co-initiated with new antidepressant with one additional short-term pivotal study
Filing pathway for postpartum depression anticipated to require one additional study without long-term follow-up
Sage Therapeutics, Inc. (NASDAQ:SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced next steps in the Landscape Program, the clinical program evaluating zuranolone (SAGE-217) for the treatment of postpartum depression (PPD) and major depressive disorder (MDD), following a Breakthrough Therapy guidance meeting with the U.S. Food and Drug Administration (FDA). Sage has identified three potential pathways intended, if successful, to support a possible filing for approval of zuranolone in the U.S. in two novel indications – PPD and acute treatment of MDD when co-initiated with a new antidepressant – along with the previously disclosed development plan for the treatment of MDD as an episodic therapy.
"Following FDA guidance, Sage has several potential pathways to bring zuranolone to patients, if we are successful, with two pathways that would represent unique indications that we believe we can progress quickly and efficiently, while in tandem we pursue our original approach to develop zuranolone for the episodic treatment of depression," said Jeff Jonas, M.D., chief executive officer of Sage Therapeutics. "The development program for zuranolone is an example of Sage's ability to think differently about depression, with the goal of providing treatment options that help people with depression get better, sooner. Sage is well-positioned for the path forward, and to continue advancing our multi-franchise strategy."