FDA approves first oral treatment for postpartum depression

The FDA has approved the first oral medication indicated for postpartum depression (PPD). Previously treatment was only available as an IV injection administers by a healthcare provider. 

“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, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research in an FDA press release. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

PPD is a major depressive episode that usually occurs following childbirth, but it can also begin during the later stages of pregnancy. It is characterized by sadness and/or loss of interest in once-enjoyable activities, with symptoms that include cognitive impairment, feelings of sadness, loss of energy, and suicidal ideation, according to the FDA. 

The labeling of Zurzuvae comes with a boxed warning that its use can affect a person’s ability to drive and perform other “potentially hazardous activities”. The drug is recommended to be taken once daily for 14 days. 

FDA granted the approval to Sage Therapeutics. 

Source: FDA News Release