The United States Food and Drug Administration (FDA) approved the Zurzuvae (zuranolone) pill for the treatment of postpartum depression (PPD) in adults on Friday (August 4). The FDA stated in a statement that the pill should be taken once a day for 14 days in the evening with a fatty meal. The recommended daily dose is 40 milligrams. Sage Therapeutics, Inc received permission for Zurzuvae, according to the release.
Dr Tiffany Farchione, FDA’s director of psychiatric drugs, said, “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,” Dr Farchione added.
The FDA said that Zurzuvae’s efficacy for the treatment of PPD in adults was proven in two investigations
The FDA said that Zurzuvae’s efficacy for the treatment of PPD in adults was proven in two investigations. Women with PPD who fulfilled the Diagnostic and Statistical Manual of Mental Disorders criteria for a severe depressive episode and whose symptoms began in the third trimester or within four weeks after birth were included in the study. Participants in the first study got 50 mg of Zurzuvae or a placebo once daily in the evening for 14 days. In Study 2, patients were given another zuranolone product equivalent to 40 mg of Zurzuvae or a placebo for 14 days.
“Patients in both studies were monitored for at least four weeks after the 14-day treatment. The primary endpoint of both studies was the change in depressive symptoms using the total score from the 17-item Hamilton depression rating scale (HAMD-17), measured at day 15,” the statement said. “Patients in the Zurzuvae groups showed significantly more improvement in their symptoms compared to those in the placebo groups. The treatment effect was maintained at Day 42—four weeks after the last dose of Zurzuvae,” it added.
The most common adverse effects of the medicine, according to the FDA, include drowsiness, dizziness, diarrhoea, exhaustion, and common cold. Suicidal thoughts and behaviour may result from the use of this medicine. “Zurzuvae may cause fetal harm,” the statement warned, adding that women should use effective contraception while taking the medicine and for one week afterwards.