SAGE Therapeutics' (SAGE) SAGE-547 Receives FDA Breakthrough Therapy Designation as Postpartum Depression Treatment

September 6, 2016 7:03 AM EDT
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Sage Therapeutics (Nasdaq: SAGE) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to SAGE-547 for the treatment of postpartum depression (PPD).

“Postpartum depression can be a devastating mental health disorder that negatively impacts all members of a family and for which there are no approved therapies. Breakthrough Therapy Designation from the FDA reflects the urgent need for treatment options for women suffering with this condition,” said Jeff Jonas, M.D., Chief Executive Officer of Sage. “Sage recently reported encouraging top-line results from our placebo-controlled Phase 2 trial in women with severe PPD in which SAGE-547 achieved a significant, rapid and durable reduction in depression scores compared with placebo. We look forward to working with the FDA to expedite the development of SAGE-547 in this indication.”

The Breakthrough Therapy Designation is intended to offer a potentially expedited development path and review for promising drug candidates, which includes increased interaction and guidance from the FDA. This regulatory decision was based primarily on the recent positive results from the Phase 2 trial of SAGE-547 in 21 patients with severe PPD. The trial met the primary endpoint of significant reduction in the Hamilton Rating Scale for Depression (HAM-D) score compared with placebo at 60 hours, with an effect that was maintained at similar magnitude through the 30-day follow-up period. SAGE-547 was generally well tolerated in the study. There were no deaths, serious adverse events or discontinuations. Detailed results of this study will be presented at the 2016 International Marcé Society Biennial Scientific Conference in Melbourne, Australia, taking place from September 26-28, 2016.

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