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FDA approves first oral drug for postpartum depression

The Food and Drug Administration on Friday approved the first pill to treat postpartum depression, a potential milestone for treating a condition that can afflict about 1 in 7 women following childbirth.

The agency announced zuranolone, under the brand name Zurzuvae, had been approved as a once-daily pill to be taken for 14 days.

“Postpartum depression is a serious and potentially 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 medication is likely to dramatically expand the number of women who can be treated for postpartum depression, when women can feel an inability to feel pleasure and even suicidal ideations following childbirth. Symptoms can also appear late during pregnancy.

Women often turn to counseling for help managing postpartum depression. Previously, the only FDA-approved treatment for postpartum depression was in the form of an IV injection, Zulresso, that could be administered only in certain health-care facilities. The pill, however, can be taken easily at home.

The medication is also significant because of how quickly it acts, particularly during the crucial first days after childbirth when women are bonding with their babies, said Samantha Meltzer-Brody, director of the Center for Women’s Mood Disorders at the University of North Carolina at Chapel Hill. Other antidepressants can take weeks, or even months, to reach 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.

The FDA warned that the drug’s side effects can include drowsiness, dizziness, fatigue, diarrhea, urinary tract infection and nasopharyngitis (the common cold). The agency also warned that patients should not drive for at least 12 hours after taking the pill; Meltzer-Brody said the medication is best taken at night before sleep.

Zuranolone is a neuroactive steroid that is closely related to allopregnanolone, a substance that occurs naturally in the body as a metabolite of the hormone progesterone. Allopregnanolone levels can rise significantly during pregnancy, but drop dramatically after childbirth, possibly contributing to postpartum depression in certain women, Meltzer-Brody said.

Researchers cautioned that there may be many underlying reasons for postpartum depression, including genetics and social determinants. Judite Blanc, an assistant professor of psychiatry and behavioral sciences at the University of Miami Miller School of Medicine, cautioned that Zurzuvae is not a “magic pill” for broadly solving postpartum depression.

She said maternal depression is also affected by factors such as lower socio-economic status, education levels and exposure to trauma and gender-based violence, particularly 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.”

Clinical trials showed the effect of Zurzuvae was maintained for four weeks after the last dose, the FDA said. The trials did not follow up with patients past 45 days, researchers cautioned.

Zurzuvae is manufactured by Sage Therapeutics, which was granted a priority and fast-track review by the FDA.

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