The first postpartum depression oral drug has been approved by the Food and Drug Administration on Friday, a possible milestone for addressing a condition that can affect about 1 in 7 women after childbirth, to treat postpartum depression.
The agency announced that it had approved zuranolone, sold as Zurzuvae, as a once-daily pill to take for 14 days.
“Postpartum depression is a serious and possibly life-threatening condition in which women experience sadness, guilt, worthlessness — even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” said Tiffany R. Farchione, the director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
The drug may greatly expand postpartum depression treatment for women with severe symptoms after childbirth. Symptoms can also appear late during pregnancy.
Women often seek counseling to manage postpartum depression. FDA previously approved postpartum depression treatment as Zulresso, an IV injection administered in select healthcare facilities. However, the pill is easily taken at home.
The drug’s quick action is significant during the early postpartum days for bonding with babies, Meltzer-Brody said. Other antidepressants can take weeks, or even months, to have their full effect, she said.
Zurzuvae “is going to be a game changer for treating maternal depression,” Meltzer-Brody said in an interview on Friday.
FDA warns of side effects: drowsiness, dizziness, fatigue, diarrhea, and urinary tract infection. Avoid driving for 12 hours.
Zuranolone, a neuroactive steroid, related to allopregnanolone, naturally occurs during pregnancy, dropping post-childbirth, possibly leading to postpartum depression.
Expert Caution and Social Factors in Postpartum Depression Treatment
Researchers cautioned that there may be many underlying reasons for postpartum depression, including genetics and social determinants. Judite Blanc, a psychiatry professor at Miami Miller School of Medicine, cautioned Zurzuvae isn’t a postpartum depression cure-all.
She said factors like lower socio-economic status, education levels, and exposure to trauma and gender-based violence also influence maternal depression, especially among women of color.
“We need to provide better social support to women,” Blanc said. “We need longer maternity leave, more flexible work schedules, and universal child care.”
The FDA reported that Zurzuvae maintained its effect for four weeks after the last dose in clinical trials.The trials did not follow up with patients past 45 days, researchers cautioned.
Sage Therapeutics manufactures Zurzuvae, which the FDA granted a priority and fast-track review.