Postpartum Depression Medication Headed to Market
By Jonathan Springston, Editor, Relias Media
The FDA has approved zuranolone (Zurzuvae), the first oral medication to treat postpartum depression (PPD).
“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. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
This oral solution could be a more convenient treatment than the current 60-hour IV injection (Zulresso). Women struggling with PPD should take 50 mg of Zurzuvae once a day, in the evening with a fatty meal, for 14 consecutive days.
Scientists studied the efficacy of zuranolone in two randomized, double-blind, placebo-controlled, multicenter studies. Participants met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and their symptoms began in the third trimester or within four weeks of delivery. In study 1, patients received 50 mg of Zurzuvae or placebo in the evening for 14 days. In study 2, patients received another zuranolone product (about 40 mg) or placebo for 14 days.
During both trials, researchers monitored patients for at least four weeks after the 14-day treatment. The primary endpoint in both studies was the change in depressive symptoms using the total score from the 17-item Hamilton depression rating scale, measured at day 15. Patients in the Zurzuvae groups showed significantly more improvement vs. those on placebo. The study authors noted the treatment effect was maintained at day 42, four weeks after the last dose of Zurzuvae.
Zurzuvae is expected to be released in the fourth quarter, but the price has not been announced. For brexalone, the IV solution, the cost is $7,450 per vial, with an average course costing about $34,000. High costs might be a barrier to access for some women.
Also, although researchers reported they observed the treatment effect at four weeks after the last dose, it is unclear if the solution will remain effective beyond that point. PPD can last months or even years for some women.
Still, Postpartum Support International (PSI) says it is optimistic “about the opportunities this new treatment offers, by providing a more accessible, and hopefully effective, treatment option for those in need.”
“Women with PPD desperately need prompt care and additional treatment options that can provide quick relief so they can be healthy and present during this momentous time in their lives,” said Wendy N. Davis, PhD, PMH-C, executive director at PSI.