Sage Wins FDA Approval for 'Game-Changing' Postpartum Depression Treatment

Randy Kelley
March 23, 2019

The drug is called Zulresso, it's an intravenous infusion of brexanolone, administered as a single, 60-hour IV drip.

"This approval marks the first time a drug has been specifically approved to treat post-partum depression, providing an important new treatment option", she added.

According to Deligiannidis, after just 60 hours had passed, almost half of the women receiving brexanolone were in remission and were no longer considered to be clinically depressed.

"Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness", according to the FDA.

The FDA approval of Zulresso is based on clinical trials in women with moderate and severe PPD, aged between 18 and 45 years who were 6 months or more postpartum at screening, and who had onset of symptoms no earlier than the third trimester and no later than the first four weeks following delivery.

Until now, the only treatment options for people with postpartum depression included counseling or talk therapy, and antidepressant medications that aren't specifically FDA-approved for helping new mothers with postpartum depression, according to the National Institute of Mental Health.

For some women who suffer from the condition, postpartum depression is debilitating, even life-threatening. This requires the drug be administered by a health care provider in a certified health care facility. It is likely to be priced $20,000-35,000 per treatment, said Sage Therapeutics, the company that developed the drug. Sage said Zulresso is expected to be available for commercialization in June, following a scheduling meeting with the FDA. Some women experienced side effects like dizziness, fatigue and headaches.

Approximately 400,000 women suffer postpartum depression in the USA every year. Symptoms improved in women receiving both the drug and the placebo-"a phenomenon common in studies of depression treatments", Belluck notes-but more women in the brexanolone reported an improvement of symptoms, and that improvement was more significant than amongst the women of the placebo group.

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Another pill, now involved in clinical trials, has also shown positive results and could be submitted for FDA approval in a couple of years, Sage Therapeutics told The New York Times.

Sage said Zulresso will cost $34,000 without insurance, plus costs for staying in a hospital or infusion center. It often ends on its own within a couple weeks, but symptoms can be different for each person. The pill, now known as SAGE-217, is produced from a comparable molecule to the particle used in Zulresso, the Times said. UNC School of Medicine (SOM) researcher Samantha Meltzer-Brody, MD, MPH, was the academic principal investigator of the trials, and says this approval could change the way postpartum depression is treated.

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