Sage Given Breakthrough Status for Postpartum Depression Drug

FDA has granted Sage Therapeutics a breakthrough therapy designation for SAGE-547 for treating postpartum depression (PPD). The company recently reported top-line results from a placebo-controlled Phase 2 trial in women with severe PPD in which SAGE-547 showed a reduction in depression scores compared with placebo. “There were no deaths, serious adverse events or discontinuations,” the company says, adding that detailed results will be presented at the 2016 International Marcé Society Biennial Scientific Conference in Melbourne, Australia 9/26-28.

SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABA receptors. It is also being developed as an adjunctive therapy for treating super-refractory status epilepticus in the Phase 3 STATUS trial (www.statustrial.com). SAGE-547 has been granted both fast track and orphan drug designations by the agency for this indication.