FDA approves first pill for postpartum depression
MIAMI - For the first time, the Food and Drug Administration has approved a pill for women dealing with postpartum depression. Clinical trial data shows the pill eases depression in a few days, faster than other anti-depressants. It's expected to be available after a 90-day review.
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.
The pill is meant to be taken for just two weeks, and the companies say many patients start to see improvement quickly.
"Women were reporting rapid improvement in their depression as early as day three," said Dr. Kristina Deligiannidis, professor at the Institute of Behavioral Science at the Feinstein Institutes for Medical Research in New York.
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 as an IV infusion. It was approved by the FDA in 2019 as the first treatment specifically for postpartum depression.
Zuranolone's label will carry 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 include drowsiness, dizziness, diarrhea, fatigue, the common cold and urinary tract infection. There is a risk of suicidal thoughts. The drug may cause fetal harm, so women taking it should use contraception, the FDA says.
The drug will need to clear a 90-day Drug Enforcement Administration scheduling process, the companies said, before it can enter the market.
The companies have not yet said how much the new drug will cost, The Associated Press reported.
