“Postpartum depression is a serious and potentially life-threatening condition in which women experience feelings of sadness, guilt, worthlessness, and, in severe cases, even thoughts of harming themselves or their children. And because postpartum depression can disrupt the mother-infant bond, it can also affect a child’s physical and emotional development,” said Tiffany, director of psychiatry at the FDA’s Center for Drug Evaluation and Research.・Mr. R. Falchione said. “For many women dealing with extreme and sometimes life-threatening emotions, the availability of oral medications could be a beneficial option.”
The drug could dramatically increase the number of women treated for postpartum depression, a condition that leaves women feeling no joy or even having suicidal thoughts after giving birth. Symptoms may appear later in pregnancy.
Women often seek counseling for postpartum depression management. It used to be the only FDA-approved treatment. postpartum depression It came in the form of an IV injection, “Zurresso,” which could only be administered at certain medical facilities. However, you can easily take the tablets at home.
Samantha Meltzer Brody, director of the Center for Women’s Mood Disorders at the University of North Carolina at Chapel, said the drug’s benefits are rapid, especially during the critical first days after childbirth, when women bond with their babies. But he said it was important. hill. Other antidepressants can take weeks or even months to take full effect, she said.
Zurzvae “will be a game-changer in treating maternal depression,” Meltzer-Brody said in an interview Friday.
The FDA warned that the drug’s side effects may include drowsiness, dizziness, fatigue, diarrhea, urinary tract infections, and nasopharyngitis (cold). The agency also warned that patients should not drive for at least 12 hours after taking the tablets. Meltzer-Brody said the drug is best taken at night before bed.
Zranolone is a neuroactive steroid that is closely related to allopregnanolone, a substance that occurs naturally in the body as a metabolite of the progesterone hormone. Allopregnanolone levels can rise significantly during pregnancy, but drop dramatically after childbirth, which may contribute to postpartum depression in certain women, Meltzer said. Brody said.
Researchers caution that postpartum depression may have many underlying reasons, including genetic and social determinants. Judith Blanc, an assistant professor of psychiatry and behavioral sciences at the University of Miami’s Miller School of Medicine, warned that the fly isn’t a “magic drug” for treating postpartum depression on a broad scale.
She said maternal depression is also influenced by factors such as lower socioeconomic status, educational levels, and exposure to trauma and gender-based violence, especially among women of color.
“We need to provide women with better social support,” Bran said. “We need longer maternity leave, more flexible work schedules, and universal childcare.”
According to the FDA, clinical trials have shown that the effects of the dregs persist for four weeks after the last dose. The researchers cautioned that the trial did not follow up patients beyond 45 days.
Zurzuvae is manufactured by Sage Therapeutics and has been granted priority and expedited review by the FDA.
