The Food and Drug Administration announced Friday 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 depression, an episode of major depression that can begin after childbirth or the later stages of pregnancy, which affects an estimated 15% of women in the weeks or months after having a baby.
“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” Dr. Tiffany Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Before this, the only approved option for treating postpartum depression was also from Sage Therapeutics: brexanolone, which is marketed as Zulresso and must be administered via an IV. Infusions of brexanolone 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 as a steroid that binds to GABA receptors within the brain, working to effectively reset neurotransmitters thrown off in patients struggling with depression.
“In people with depression, it may help to rapidly 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 in a release last year.
The companies had touted the once-daily pill, intended to be taken over only two weeks, as part of a potential new “paradigm” for how major depression might soon be treated. They sought FDA approval for it 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 will need to clear a 90-day Drug Enforcement Agency scheduling process, the companies said, before it can enter the market.
This is a developing story and will be updated.
