The Food and Drug Administration is expected to reveal whether it has approved the first pill to treat postpartum depression later this year.
Zuranolone is a 14-day oral treatment for adults with postpartum depression or major depressive disorder.
“We see potential for zuranolone, if approved, to be a meaningful new option that can help address the serious unmet need faced by the diverse populations struggling with MDD and PPD,” said Dr. Priya Singhal, executive vice president at Biogen, which partnered with Sage Therapeutics to develop the treatment.
The companies say the medication targets brain networks responsible for functions such as mood, arousal, behavior, and cognition.
Their application has been granted priority review and the FDA is expected to deliver a decision on Aug. 5.
Postpartum depression occurs after a woman gives birth. Symptoms include feelings of anger, thinking about hurting the baby, doubts about the ability to care for the child and withdrawing from loved ones.
According to the Centers for Disease Control and Prevention, about 1 in 8 women experience symptoms of postpartum depression.
“We feel a tremendous responsibility to patients with MDD and PPD to deliver a potential new treatment option, which is so desperately needed. Most current approved therapies may take weeks or months to work. We are committed to advancing treatments that could help physicians and patients by addressing depression symptoms quickly,” said Dr. Laura Gault, chief medical officer at Sage.
