Toluca, Mexico; August 5, 2023.
andThe U.S. Food and Drug Administration has approved Zurzuvae (zuranolone), the first oral medication for the treatment of postpartum depression in adults.
Postpartum depression is a severe depressive episode that usually occurs after childbirth, but can also begin later in pregnancy.
So far, his treatment has only been administered intravenously by medical providers in certain medical institutions.
“Postpartum depression is a serious and life-threatening disorder in which women experience feelings of sadness, guilt, worthlessness and, in severe cases, thoughts of harming themselves or their children,” said Tiffany R, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. Farchione says that because postpartum depression can disrupt the mother-infant relationship, it can also have an impact on the child’s physical and emotional development.
Like other forms of depression, postpartum depression is characterized by sadness, loss of interest in activities that used to be enjoyed, and a decreased ability to feel joy.
Efficacy and Research:
The efficacy of Zurzuvae for the treatment of postpartum depression in adults has been demonstrated in two multicenter, randomized, double-blind, placebo-controlled studies.
Trial participants were women with postpartum depressive symptoms who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and whose symptoms began in the third trimester or within four weeks of delivery.
In Study 1, patients received Zurzuvae 50 mg or placebo once daily in the evening for 14 days. In Study 2, patients received another zuranolone product at a dose approximately equivalent to Zurzuvae 40 mg or placebo, also for 14 days.
Patients in both studies were monitored for at least 4 weeks after 14 days of treatment. The primary endpoint of both studies was change in depressive symptoms.
Patients in the Zurzuvae group experienced significant improvement in symptoms compared to the placebo group.
side effect:
The most common side effects include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (common cold), and urinary tract infection.
Use of Zurzuvae may cause suicidal thoughts and behaviors or fetal harm.
Information from: FDA