FDA grants Breakthrough Therapy Designation to SAGE-547 for postpartum depression
The FDA recently granted Breakthrough Therapy Designation to SAGE-547, an IV treatment for postpartum depression.
“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,” Jeff Jonas, MD, CEO of Sage Therapeutics, said in a press release.
The designation was based on recently released phase 2 study results. The study assessed SAGE-547 among 21 individuals with postpartum depression.
At 60 hours, Hamilton Rating Scale for Depression scores were significantly lower among women who received SAGE-547, compared with placebo. This effect was maintained throughout the 30-day follow-up.
The treatment was generally well-tolerated and there were no deaths, serious adverse events or discontinuations, according to the release.
“Sage recently reported encouraging top-line results from our placebo-controlled phase 2 trial in women with severe [postpartum depression] in which SAGE-547 achieved a significant, rapid and durable reduction in depression scores compared with placebo,” Jonas said in the release. “We look forward to working with the FDA to expedite the development of SAGE-547 in this indication.”