Sage wins historic FDA nod for postpartum depression therapy

Sage Therapeutics (NSDQ:SAGE) this week won FDA approval for the first medicine indicated to treat postpartum depression.

The Cambridge, Mass.-based company’s injection therapy, Zulresso, is slated to be available in late June.

Postpartum depression is the most common medical complication of childbirth, according to Sage, and affects roughly one in nine women who have given birth in the U.S.

In clinical trials, people treated with Zulresso saw a reduction of depressive symptoms as early 24 hours and the therapy maintained its effects through the 30-day follow-up period. The most common adverse events observed in the studies were sleepiness, dry mouth, loss of consciousness and flushing.

“We are proud to be a part of this important moment in mental health, creating the opportunity for an unprecedented change in the way postpartum depression is thought about and treated moving forward,” CEO Dr. Jeff Jonas said in prepared remarks. “We are grateful for the patients, researchers, healthcare providers, advocates, caregivers and Sage employees who helped secure the approval of the first medicine specifically for postpartum depression.

Not only do we believe Zulresso will address an important need for women’s mental health, the impact of PPD is multi-generational, and we look forward to bringing Zulresso to patients in urgent need of a new treatment option. We believe Zulresso will be a catalyst in starting a new dialogue emphasizing the importance of women’s mental health, and the importance of diagnosing and treating PPD,” Jonas added.

Sage plans to list Zulresso at $7,450 per vial, a company spokesperson told Endpoints News. The company is also working on an oral therapy for postpartum depression and major depressive disorder – one that would avoid the issues with fainting linked with Sage’s injection therapy.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.