FDA Approves Zuranolone for Postpartum Depression

Last week, the United States Food and Drug Administration approved the first oral treatment for postpartum depression (PPD). Zuranolone was approved on August 4, 2023, just days after a study in the American Journal of Psychiatry confirmed its safety and efficacy.

“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, MD, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in the FDA press release. 

While many patients experience postpartum sadness and mood swings due to hormonal changes,  Postpartum depression symptoms may include difficulty bonding with the baby, irritability, shame, anxiety, self-harm, and panic attacks.

These symptoms must last over two weeks after childbirth to be considered PPD; however, a study published in Pediatrics implies that 25% of PPD patients are still experiencing symptoms after three years. A report in Current Psychiatry Reports estimates that 20% of postpartum deaths are linked to PPD.

According to the FDA press release, until now, PPD has only been treated with an IV injection under the advisement of a licensed healthcare professional. However, this treatment option presents a barrier to care.  

“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” added Farchione.

The FDA granted approval for zuranolone to Sage Pharmaceuticals, which will sell the drug under the brand name Zurzuvae. Approval was based on data submitted by the company and published in the American Journal of Psychiatry on July 26, 2023. The data showed that the 14-day treatment reduced depression symptoms in women who met the DSM-5 diagnostic guidelines for PPD.

As this new drug comes to market, providers may offer the recommended dose of 50 mg daily for 14 days. The recommendations also advise patients to take the pill at night with a fatty meal. Providers are also urged to inform their patients of potential side effects, including drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infections.