After a Breakthrough Therapy guidance meeting with the US Food & Drug Administration (FDA), Sage Therapeutics announced plans to launch 3 additional studies of its investigational drug zuranolone.
If successful, the studies could lead toward 3 distinct indications for the medication: for use as an oral therapy in women with postpartum depression, for use as an acute rapid response therapy in patients with major depressive disorder (MDD) when co-initiated with new standard antidepressant therapy, and for use as an episodic therapy in patients with MDD.
“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, MD, chief executive officer of Sage Therapeutics, in a company press release.
The 3 new placebo-controlled studies are set to begin this year and are in addition to 3 already completed efficacy studies for the rapid-acting, short-course treatment. Each of the new studies will evaluate a 2-week course of zuranolone 50 mg; in a trial testing its efficacy as acute treatment for MDD with a new standard antidepressant, it will be co-initiated with an open-label selective serotonin reuptake inhibitor. Results are expected in 2021.
Zuranolone, an investigational oral neuroactive steroid GABAA receptor positive allosteric modulator, was previously granted a Breakthrough Therapy designation by the FDA.
Sage Therapeutics announces development plan for zuranolone (SAGE-217) following breakthrough therapy guidance meeting with the U.S. Food & Drug Administration [press release]. Cambridge, Massachusetts: Sage Therapeutics; March 18, 2020.