Clayton, a primary investigator in the drug's pivotal trials, discusses what the historic FDA approval means for managing PPD in women.
On Friday evening, the US Food and Drug Administration (FDA) approved the New Drug Application (NDA) for zuranolone, a once-daily, 14-day oral tablet indicated for the treatment of postpartum depression (PPD).
While indication for a fast-acting agent designed to target the neuroactive steroid GABA-A receptor has benefit for the entirety of depression care, its ndication for women with PPD is historic—being the first antidepressant drug on the market for such a condition.
In an interview with HCPLive, zuranolone investigator Anita Clayton, MD, Wilford W. Spradlin Professor and Chair of the department of psychiatry & neurobehavioral sciences, and professor of clinical obstetrics & gynecology at the University of Virginia School of Medicine, discussed the implication of zuranolone’s approval for PPD.
“It’s completely paradigm-shifting,” Clayton said. “You know that 10 – 15% of women experience a postpartum depression; at a year, 43% are still ill, and looking at even…3 years, a very similar percentage are not well.”
As a neurosteroid, zuranolone provides direct action to steroid levels in the body that heighten during pregnancy—essentially resulting in more efficacious clinical outcomes in women with PPD than even in adults with MDD. Clayton stressed the cruciality of such a breakthrough at a time when PPD is frequently unchecked and under-addressed in women.
“We need to get women better, because there are impacts on babies, in terms of their development, their relationships and attachment,” Clayton said. “It’s just critical we get women with postpartum depression identified, treated, and with rapid and full improvement.”
Speaking to the broad clinical profile of zuranolone in treating depression, Clayton pointed to one clear advantage it provides. “We don’t have anything that is a short course, that works rapidly, that the effect is maintained, and the side effects are minimal.”