The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to SAGE-547 (Sage Therapeutics) for the treatment of postpartum depression (PPD).
The designation was based on recent encouraging data from the multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase 2 trial of SAGE-547 in 21 patients with severe PPD. The company reported positive results showing that treatment with SAGE-547 achieved a significant, rapid and durable reduction in the Hamilton Rating Scale for Depression (HAM-D) scores vs. placebo, meeting the study’s primary endpoint. Reduction in depression scores for SAGE-547 was achieved at 60 hours, with an effect that was maintained at similar magnitude through the 30-day follow-up period.
The study found SAGE-547 to be generally well-tolerated, with no reported deaths, serious adverse events or drug discontinuations. Detailed findings will be presented at the 2016 International Marcé Society Biennial Scientific Conference on September 26-28, 2016.
SAGE-547 is an intravenous, allosteric modulator of both synaptic and extra-synaptic GABAA receptors. In addition to PPD, it is also being investigated as an adjunctive therapy for the treatment of super-refractory status epilepticus (SRSE).
For more information visit Sagerx.com.