FDA Approves First Oral Treatment for Postpartum Depression

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However, the FDA said an application for zuranolone to treat major depressive disorder did not provide substantial evidence of efficacy.

The FDA has approved zuranolone (Zurzuvae, Sage Therapeutics) as the first oral medication to treat postpartum depression (PPD) in adults.1

Prior to this approval, treatment for PPD was only available via intravenous injection administered by a health care provider in specific health care facilities. PPD is defined as a major depressive episode that typically occurs after childbirth, but can also begin in the later stages of pregnancy.1 Symptoms 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.2

“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 a 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.”1

CDC data show that mental health conditions are the leading cause of maternal mortality, with PPD among the most common complications during and after pregnancy. Approximately 1 in 8 women in the United States experience symptoms of PPD and nearly half may go undiagnosed without appropriate screening. Notably, research shows that only 15.8% of women with PPD symptoms receive treatment.2

The approval is based on the NEST clinical development program, which included 2 studies in adult women with PPD—the ROBIN and the SKYLARK studies. Both studies met their primary endpoint of a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression total score at day 15 as compared to placebo.2

In the SKYLARK study, which evaluated zuranolone 50 mg, all key secondary endpoints were met, with a significant reduction in depressive symptoms as early as day 3 and sustained through day 45.2 In the ROBIN study, patients received another zuranolone product that was approximately equal to 40 mg of Zurzuvae or placebo for 14 days. In both studies, patients were monitored for at least 4 weeks after the 14-day treatment.1

Treatment with zuranolone was generally well-tolerated with a consistent safety profile in both studies. The most common adverse effects in patients treated with zuranolone 50 mg were somnolence, dizziness, diarrhea, fatigue, and urinary tract infection.2

“Today marks a groundbreaking day for the treatment of PPD, as with Zurzuvae we now have an oral treatment option that can provide rapid improvements in depressive symptoms in as early as 3 days for women with PPD,” said Kristine Deligiannidis, MD, a principal investigator in the Zurzuvae clinical development program, in a press release. “As a perinatal psychiatrist, I see the devastating impact PPD has on mothers, particularly on the important mother-infant bond and long-term child development. Once available, I believe Zurzuvae will be a meaningful option for patients in need.”

The labeling includes a boxed warning noting that Zurzuvae can impact a patient’s ability to drive and perform other potentially hazardous activities. Patients may not be able to assess their degree of impairment and should not drive or operate heavy machinery for at least 12 hours after taking Zurzuvae.1

Zuranolone may cause fetal harm and women should use effective contraception while taking and for 1 week after taking zuranolone. The daily recommended dose is 50 mg and patients should be instructed to take it once daily for 14 days in the evening with a fatty meal.1 It is expected to launch and be commercially available in the fourth quarter of 2023.2

In addition to its approval, 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 efficacy to support the approval of zuranolone to treat MDD and additional studies will be needed.2

“Maternal mental health has been sidelined for far too long, but today’s approval of Zurzuvae helps to change that. Women have been waiting for an oral medication that can specifically and rapidly improve the symptoms of PPD and we are proud to be able to deliver that,” said Barry Greene, CEO at Sage Therapeutics, in a press release. “In regard to the CRL for MDD, we are highly disappointed for patients, particularly amid the current mental health crisis and millions of people with MDD struggling to find symptom relief.”2

The company said it is reviewing the feedback and evaluating next steps.2

References

  1. FDA Approves First Oral Treatment for Postpartum Depression. News release. FDA. August 4, 2023. Accessed August 7, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression
  2. 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. News release. Sage Therapeutics. August 4, 2023. Accessed August 7, 2023. https://investor.sagerx.com/news-releases/news-release-details/fda-approves-zurzuvaetm-zuranolone-first-and-only-oral-treatment
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