First postpartum depression drug gets FDA nod

By Dr. Ananya Mandal, MDMar 20 2019

Sage therapeutics’ Zulresso became the first drug approved for postpartum depression by the United States Food and Drugs Administration (FDA). This cause the shares of Sage to rise by over 5 percent on Tuesday this week.

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Brexanolone brand named Zulresso, is being approved for intravenous use in treatment of life-threatening postpartum depression. Postpartum depression or “baby blues” commonly occurs just before and right after childbirth and can be severely debilitating to the mother. There is a major depressive episode that may adversely affect the mother as well as the baby. Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research in a statement said, “Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond.” Postpartum depression affects one in nine mothers after delivery.

At present the newly approved drug Zulresso is to have a restricted use and availability only. It would be given under a restricted program called the “Zulresso Risk Evaluation and Mitigation Strategy (REMS) Program”. The main reason behind this is the side effects of the drug such as excessive sedation and sudden unconsciousness when the drug is administered. The drug would be administered only by a health care provider at a certified health care facility only said the FDA in a news release.

For this approval, the manufacturers presented the results of two clinical trials where Zulresso was found to be superior to placebo in improving the symptoms of postpartum depression after the first infusion dose.

Brexanolone is a synthetic form of the compound allopregnanolone which is a hormone produced by the female hormone progesterone in the brain. Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina at Chapel Hill, the principal investigator of the brexanolone studies explained that this hormone can reduce the symptoms of anxiety and depression in the brain of the patient with postpartum depression.

The approved dose of the drug is a single 60-hour intravenous infusion. The likely price of the drug would be around $20,000 to $35,000 per treatment according to the makers, Sage. Dr. Jeff Jonas, CEO of the Massachusetts-based biopharmaceutical company Sage Therapeutics who is also a psychiatrist, said that the drug would be available from June this year. He said initially the drug would be supplied only in hospitals but the team was also tapping the potential use among family practitioners, paediatricians and practicing obstetricians.