On Aug. 4, 2023, Biogen and Sage Therapeutics announced that the U.S. Food and Drug Administration (FDA) had approved ZURZUVAE (zuranolone) 50 mg for adults with postpartum depression (PPD). ZURZUVAE was the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD.

The approval of ZURZUVAE to treat women with PPD was based on the NEST clinical development program, which included two studies in adult women with PPD (ROBIN and SKYLARK Studies). Both studies met their primary endpoint.

According to the Centers for Disease Control and Prevention, mental health conditions are the leading cause of maternal mortality with PPD among the most common complications during and after pregnancy.

In the U.S., it is estimated approximately 1 in 8 women experience symptoms of PPD. Approximately half of all PPD cases may go undiagnosed without appropriate screening. Research shows only 15.8% of women with PPD symptoms receive treatment. PPD symptoms may persist beyond the postpartum period and can lead to prolonged maternal morbidity.

Symptoms of PPD can include depressed mood, loss of interest in activities, changes in sleep patterns and appetite, decreased energy, feelings of guilt or worthlessness, trouble concentrating and in some cases thoughts of suicide.