Silver Spring, MD—Until recently, treatment for women suffering from postpartum depression (PPD) was limited to IV injection given by a healthcare provider in certain facilities.

Recently, however, the FDA approved zuranolone—marketed as Zurzuvae—as the first oral medication indicated to treat PPD in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy, according to the FDA. The FDA granted the application under Priority Review and Fast Track designations.

“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,” stated Tiffany R. Farchione, MD, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

Other symptoms can include cognitive impairment, feelings of sadness or inadequacy, loss of energy, and suicidal ideation.

The drug is expected to be commercially available in the fourth quarter of 2023, shortly after its scheduling as a controlled substance by the U.S. Drug Enforcement Administration. Scheduling is anticipated to occur within 90 days, according to Sage Therapeutics, Inc.

The efficacy of Zurzuvae for the treatment of PPD in adults was demonstrated in two randomized, double-blind, placebo-controlled, multicenter studies. The trial participants included women with PPD who met Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and whose symptoms began in the third trimester or within 4 weeks of delivery. In the first study, patients received 50 mg of Zurzuvae or placebo once daily in the evening for 14 days; in the second study, patients received another zuranolone product that was approximately equal to 40 mg of Zurzuvae or placebo, also for 14 days. The researchers monitored participants for at least 4 weeks after the 14-day treatment.

The primary endpoint of both studies was defined as the change in depressive symptoms using the total score from the 17-item Hamilton Depression Rating Scale (HAMD-17), measured on Day 15. The FDA reported that 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.”

Pharmacists should be aware that the labeling contains a boxed warning noting that Zurzuvae can impact a person’s ability to drive and perform other potentially hazardous activities. Because patients also might not be able to assess their degree of impairment, they should avoid driving or operating heavy machinery for at least 12 hours after taking Zurzuvae.

The most common side effects include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (the common cold), and urinary tract infection. Use of Zurzuvae might also cause suicidal thoughts and behavior, the FDA cautioned.

Because Zurzuvae may cause fetal harm, women should use effective contraception while taking, and for 1 week after taking the drug. The daily recommended dose of Zurzuvae is 50 mg. Zurzuvae should be taken once daily for 14 days in the evening with a fatty meal.

Sage Therapeutics also noted in a press release that the FDA issued a Complete Response Letter (CRL) for the New Drug Application for zuranolone in the treatment of adults with major depressive disorder (MDD). The CRL stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that an additional study or studies will be needed. Sage Therapeutics said that it and its partner company Biogen are reviewing the feedback and evaluating the next steps.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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