In a historic breakthrough, the U.S. Food and Drug Administration (FDA) has granted approval for the first at-home oral pill, Zurzuvae (zuranolone), to treat perinatal or postpartum depression (PPD). This monumental decision is the result of decades of preclinical research and the most recent phase 3 clinical trials led by Dr. Kristina M. Deligiannidis, a professor at the Institute of Behavioral Science at The Feinstein Institutes for Medical Research. The drug, sold under the brand name Zurzuvae, offers new therapeutic options for the one in eight birthing women who experience PPD, significantly alleviating depressive symptoms with promising rapid results.
Just days after the publication of the SKYLARK Study's findings, a phase 3 placebo-controlled clinical trial of zuranolone (50mg), the FDA announced the approval of Zurzuvae. The results from the trial, published in The American Journal of Psychiatry, revealed that women experienced rapid, clinically meaningful improvements in their depressive symptoms. Some participants reported significant relief by day three (after two doses), which persisted through day 45, marking the end of the trial.
Dr. Deligiannidis emphasized the importance of this FDA decision, stating that PPD is often underdiagnosed and undertreated. With Zurzuvae now available, she believes this new at-home, 14-day treatment option can reverse this trend and help many more women in need. The drug offers hope to those suffering from the condition and opens the door to more accessible and effective treatment options.
Evidence from the SKYLARK and ROBIN clinical trials supported the FDA's approval of zuranolone. These trials demonstrated substantial improvements in depressive symptoms in women with PPD. It is suggested that PPD is partly linked to a disruption in the normal interaction between the nervous system's stress response, ɣ-aminobutyric acid (GABA) signaling, and neuroactive steroids (NAS). The breakthrough achieved by Zurzuvae addresses this imbalance and shows promising results in managing PPD.
Dr. Kristina M. Deligiannidis, through her dedicated research and collaboration with scientists worldwide, has significantly contributed to the understanding of neuroactive steroids' role in perinatal depression. Over the past 15 years, she has received research support from the National Institutes of Health (NIH) and non-profit foundations to explore how these steroids impact brain chemistry and circuitry in perinatal women. Her leadership in clinical trials for PPD led to the FDA's approval of the intravenous drug brexanolone (Zulresso) in 2019. However, the need for infusion clinics was a barrier to care, making zuranolone's pill form a game-changer.
The Feinstein Institutes, under Dr. Deligiannidis's guidance, continues to pioneer new diagnostic and treatment methods for perinatal depression. Multi-year grants of over $4 million have been awarded to study non-invasive brain imaging for understanding the condition's development in women. Novel treatments, such as bright light therapy, sleep modification, and non-invasive vagus nerve stimulation, are being explored to treat major depressive disorders.
The FDA's approval of the at-home oral pill Zurzuvae, containing zuranolone, marks a groundbreaking milestone in women's behavioral health. The dedication of scientists worldwide, including Dr. Kristina M. Deligiannidis and her team at The Feinstein Institutes, has paved the way for new therapeutic options to address perinatal and postpartum depression. With the potential for rapid symptom relief and improved accessibility, Zurzuvae offers hope to countless women, empowering them to overcome the challenges of PPD and embrace a healthier, happier postpartum journey.