FDA approves first oral medication to treat postpartum depression

Key takeaways:

• Zuranolone is the first oral treatment for postpartum depression.
• Approval was based on studies showing improvement in postpartum depression symptoms.
• FDA did not approve zuranolone for major depressive disorder.

The FDA approved zuranolone as the first oral treatment for postpartum depression in adults, according to an agency press release.

Prior to this approval, medication treatment for postpartum depression was available only through IV injection given by health care providers in certain facilities. Zurzuvae (zuranolone, Sage Pharmaceuticals) is now the first and only oral, once daily treatment approved for postpartum depression.

“Approval of zuranolone would be very exciting because it is a fast-acting antidepressant, which makes it unique. Selective serotonin reuptake inhibitors [considered the first-line antidepressant treatment and not specifically approved for postpartum depression] can take 4 to 6 weeks to be effective,” Samantha Meltzer-Brody, MD, MPH, chair of the department of psychiatry at the University of North Carolina School of Medicine at the University of North Carolina at Chapel Hill, told Healio in May. “In the zuranolone clinical trials, you see onset of action at day 3 of a 14-day treatment trial, and that effect persists out to 45 days of the study period in all the clinical trials. Something that really is having a positive impact by day 3 is a marked step forward.”

The approval is based on the efficacy of zuranolone for postpartum depression treatment demonstrated in the ROBIN and SKYLARK studies — two randomized, double-blind, placebo-controlled, multicenter studies — which showed that women with postpartum depression who received zuranolone 50 mg once daily for 14 days had significantly more improvement in their symptoms compared with the placebo groups. The effect was maintained for 42 days after the last dose of zuranolone.

The FDA is requiring zuranolone to include a black box label warning that use could impair a patient’s ability to drive or conduct potentially hazardous activities and that impairment may not be easy to assess.

The most common adverse effects associated with use of zuranolone were drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis and urinary tract infection. In addition, zuranolone use might cause suicidal thoughts and behavior and might affect a fetus. Patients should use effective contraception while taking zuranolone and for 1 week after use, according to the release.

“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,” Tiffany R. Farchione, MD, director of the division of psychiatry at the Center for Drug Evaluation and Research at the FDA, said in the 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.”

The FDA also issued a Complete Response Letter declining to approve zuranolone for major depressive disorder in adults, according to a press release from Biogen and Sage Pharmaceuticals. The agency said the companies did not provide substantial evidence of effectiveness of zuranolone for that disorder.

Zurzuvae is expected to launch and be commercially available in the fourth quarter of 2023 shortly following scheduling as a controlled substance by the U.S. Drug Enforcement Administration, which is anticipated to occur within 90 days, according to the Sage press release.

Reference:

• FDA Approves ZURZUVAE (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder. https://investor.sagerx.com/news-releases/news-release-details/fda-approves-zurzuvaetm-zuranolone-first-and-only-oral-treatment. Published Aug 4, 2023. Accessed Aug 7, 2023.