FDA Approves First-Ever Drug for Postpartum Depression
Patients have to visit a treatment center for a one-time, 60-hour intravenous infusion.
The first drug specifically developed for postpartum depression was approved by the FDA on Tuesday, opening a potential treatment option that could save women’s lives.
It’s called brexanolone, or Zulresso, and is unique because it has a synthetic form of the hormone allopregnanolone, a progesterone derivative, in it, according to NBC News. The hormone increases in women during pregnancy and then plummets after she gives birth — what some experts consider to be a contributor to postpartum depression.
While there are some mild, potential side effects from the drug, like drowsiness and dizziness, the biggest hurdle for most patients will likely be its hefty price tag: brexanolone is expected to cost somewhere between $20,000 to $35,000. It is not clear yet how much insurance will cover.
“This can potentially transform women’s lives and that of their families,” said Dr. Steve Kanes, chief medical officer of Sage Therapeutics, the Cambridge, Mass., biopharmaceutical company that developed brexanolone. “It’s not just the mother who suffers when there’s postpartum depression. It’s the newborn. It’s the other people in their family.”
Unlike traditional antidepressants, brexanolone is not a pill that patients swallow. The drug is instead administered intravenously during a 60-hour infusion at a medically supervised setting, like a hospital.
During clinical trials, some women with moderate to severe postpartum depression experienced instant relief with many more feeling a noticeable change within 24 hours.
“This is for postpartum depression, but it is a step in understanding how we treat depression more broadly,” said Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina at Chapel Hill and the academic principal investigator in the brexanolone trials. “We have had the same treatments for depression for 30 years. There’s an enormous need for new, novel ways to treat depression, and to treat it quickly.”
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