After giving birth to her oldest daughter 11 years ago, Charleston County resident Elaine DeaKyne went through “pretty severe postpartum depression” – to the point of needing support from Postpartum Support Charleston, where she serves as executive director.
Zurzuvae – a new drug that was approved by the Food and Drug Administration on Aug. 4, 2023 – is a game changer for women like DeaKyne. It is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD.
“Postpartum depression was not on my radar at all – so having this pill validates what new mothers are facing all the time,” DeaKyne said. “As a person who struggled and who works with mothers all the time who are struggling, it’s really, really a significant step for maternal health.”
“Women have been waiting for an oral medicine that can specifically and rapidly improve the symptoms of PPD,” said Barry Greene, CEO of Sage Therapeutics, a biopharmaceutical company in Cambridge, Massachusetts, and the chief testing company for the new drug. “And we are proud to be able to deliver that.”
The breakthrough pill came after seven years of clinical trials testing, both by Sage Therapeutics and Biogen, a global biotechnology company that also calls Cambridge home. The new pill is expected to be commercially available in the fourth quarter of 2023, after the Drug Enforcement Administration finishes scheduling it as a controlled substance.
“The approval of Zurzuvae to treat postpartum depression is a major milestone for the hundreds of thousands of women who experience this underdiagnosed and undertreated condition,” said Christopher A. Viehbacher, president and CEO at Biogen. “We appreciate the support of patients, patient advocates and researchers who helped to reach this milestone.”
One of the researchers was Dr. Connie Guille, director of the Women’s Reproductive Behavioral Health Division at the Medical University of South Carolina in Charleston.
“Sage developed the compound and reached out to sites across the country to take part in the clinical trials,” Dr. Guille said. “I had worked with them before as a content expert on postpartum depression, and, in addition to MUSC, where we did the clinical trial, there were at least 10 to 15 other testing sites around the country.”
She added that the trials held particular, personal interest for her because of her experience seeing “so many women suffering with this condition for a very long time.”
Researchers with the National Institutes of Health in Bethesda, Maryland, estimate that 1 in 7 women can develop postpartum depression, which tends to severely affect their ability to return to normal function. Risk factors include depression and anxiety, negative attitudes toward the baby, crying, irritability and adverse changes in sleeping or eating patterns.
“We know that at this point in our country, maternal mental health conditions are the leading cause of maternal mortality by suicide and drug overdose,” Dr. Guille said. “We are thrilled to have new and effective treatments available for women.”
Selective serotonin reuptake inhibitors are currently the medications used for the treatment of post-partum depression. Dr. Guille said that while SSRIs take six weeks or more to relieve PPD symptoms, for some women, the symptoms can persist for a year without treatment.
“The clinical trials with Zurzuvae demonstrate significant improvement in symptoms in two to three days,” she said. “FDA approval of Zurzuvae is a great advancement in the treatment of PPD, and I hope it will be a medication that is available and accessible to all women in need of this treatment.”
By L. C. Leach III
