The Food and Drug Administration announced Friday that it has approved the first oral treatment for postpartum depression. The drug, called zuranolone, is a once-a-day pill that will be branded as Zurzuvae by drugmakers Sage Therapeutics and Biogen.
Zuranolone is approved for use in adults for the treatment of postpartum depressionan episode of major depression that may begin after delivery or in the later stages of pregnancy, affecting an estimated 15% of women in the weeks or months following delivery.
“Having access to oral medications will be a beneficial option for many of these women dealing with extreme and sometimes life-threatening feelings,” Dr. Tiffany Farchione, director of the Department of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said a statement.
Previously, the only approved option for treating postpartum depression was also from Sage Therapeutics: brexanolone, which is marketed as Zulresso and must be administered through an IV. Brexanolone infusions were approved by the FDA in 2019 as the first treatment specifically for postpartum depression.
Similar to that drug, Sage and Biogen say they think zuranolone acts like a steroid that binds to GABA receptors in the brain, effectively resetting neurotransmitters in patients struggling with depression.
“In people with depression, it can help quickly rebalance dysregulated neuronal networks to help restore brain function. Zuranolone targets brain networks responsible for functions such as mood, arousal, behavior and cognition,” the companies said last week. years in a release.
Zuranolone’s label carries a boxed warning that patients should not drive or operate machinery for 12 hours after taking the drug. The FDA says the most common side effects are drowsiness, dizziness, diarrhea, fatigue, cold, and urinary tract infection. There is a risk of suicidal thoughts. The drug can cause fetal harm, so women taking it should use birth control, the FDA says.
The companies had touted the once-daily pill, intended to be taken within two weeks, as part of a possible new “paradigm” for how severe depression could soon be treated. They sought FDA approval to treat both postpartum depression and major depressive disorder.
However, with Friday’s decision, the FDA only formally approved the drug for postpartum depression.
The drug must go through a 90-day planning process by the Drug Enforcement Agency, the companies said, before it can hit the market.
This is a developing story and will be updated.
