US: FDA approves first oral pill to treat postpartum depression. Check details here

The United States Food and Drug Administration (FDA) on Friday (August 4) approved the use of the Zurzuvae (zuranolone) pill to treat postpartum depression (PPD) in adults. In a statement, the FDA said that the pill is to be taken once every day for 14 days during the evening with a fatty meal. The daily recommended dosage is 40 milligrams. The approval of Zurzuvae was granted to Sage Therapeutics, Inc, the statement added.

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."

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"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 studies conducted for Zurzuvae's efficacy

The FDA said that the efficacy of Zurzuvae for the treatment of PPD in adults was demonstrated in two studies. The participants were women with PPD 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 the first study, the participants received 50 mg of Zurzuvae or placebo once daily in the evening for 14 days. In Study 2, patients received another zuranolone product that was approximately equal to 40 mg of Zurzuvae or placebo, also 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.

What are the side effects of the drug?

As per the FDA, the most common side effects of the drug include drowsiness, dizziness, diarrhoea, fatigue, and a common cold. The use of this drug may also cause suicidal thoughts and behaviour. "Zurzuvae may cause fetal harm," the statement said, adding women should use effective contraception while taking, and for one week after taking the drug.

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