The U.S. Food and Drug Administration has approved a drug meant to specifically treat postpartum depression in mothers, a first for the agency.
The FDA announced in a news release Tuesday that it approved an intravenous infusion of brexanolone, a drug labeled as Zulresso. Patients would receive a continuous IV drip over 60 hours. The news release said clinical trials, which involved more than 200 women, showed brexanolone worked within hours to help treat postpartum depression, which affects 1 in 9 new mothers.
Postpartum depression is much more severe and longer-lasting than the “baby blues” many new mothers experience for about a week after giving birth. Symptoms of postpartum depression can include sadness, loss of interest, difficulty bonding with the baby and even suicidal thoughts.
“Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond,” said Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”
Zulresso will be provided only through a Risk Evaluation and Mitigation Strategy (REMS) program that requires that a health care provider administer the drug in a certified health care facility. Farchione said the REMS program is necessary “because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration.”
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.
The treatment’s 60-hour length could make it difficult for some new mothers to be able to participate ― after all, it involves sedation, and patients must be accompanied when interacting with their children during the infusion, according to the release. This is in addition to the treatment cost, which CNN said will likely be $20,000 to $35,000 per treatment, according to Sage Therapeutics, the biopharmaceutical company that created the treatment. Mothers without extra home support and low-income mothers are often particularly prone to postpartum depression.
Also, Sage Therapeutics advised that patients talk to their doctor about breastfeeding because the drug will pass into breast milk.
The treatment is expected to be available starting in June after the U.S. Drug Enforcement Administration schedules the drug, which will happen within about 90 days.