SAGE-547 Receives FDA Breakthrough Designation for Postpartum Depression
FDA granted a Breakthrough Therapy Designation to SAGE-547, an intravenous treatment for postpartum depression.
Sage Therapeutics, the drug’s sponsor, released results in July from a Phase II trial that showed SAGE-547 met its primary endpoint of lowering depression scale ratings in patients within 60 hours, compared to placebo, with effects maintained at similar magnitude for 30 days. SAGE-547 is also being developed as an adjunctive therapy for the treatment of super-refractory status epilepticus in the global Phase III trial.
The breakthrough designation is intended to offer a potentially expedited review for drug candidates that treat life-threatening diseases or conditions, and can include increased interaction and guidance from FDA. It does not change the standard for approval.