Postpartum depression pill zuranolone yields "significant improvements," clinical trial data shows
A pill being developed to treat postpartum depression is showing promise for new parents who suffer from the condition, according to newly released clinical trial data.
The study, published Wednesday in The American Journal of Psychiatry, found the drug, zuranolone, from makers Sage Therapeutics and partner company Biogen, demonstrated "significant improvements in depressive symptoms and was generally well tolerated."
The late stage, double-blind trial analyzed nearly 200 patients with severe postpartum depression who were given either 50 milligrams per day of zuranolone or a placebo for 14 days.
"Treatment with zuranolone compared with placebo resulted in statistically significant improvements in symptoms at day 15," the researchers reported.
The most common adverse effects reported with the drug were somnolence (drowsiness), dizziness and sedation. "No loss of consciousness, withdrawal symptoms, or increased suicidal ideation or behavior were observed," the study authors wrote.
Zuranolone is designed to be taken as a once-a-day pill for 14 days. It is not yet approved by the Food and Drug Administration, but the agency is expected to make a decision on it in early August.
If approved, it could offer a new option for some of the estimated 1 in 8 women who experience symptoms of postpartum depression, which can include sadness, anxiety, irritability, loss of appetite and even self-harm.
Currently, there is only one drug on the market specifically designed to treat postpartum depression: Zulresso, developed by Sage. That drug, launched in 2019, is given intravenously to patients for 60 hours in a health care setting.
A 14-day, fast-acting daily pill option, if approved, could make treatment more accessible.
"Of course, we think that zuranolone will be accessible to many, many more patients and we're excited by that, to really fulfill that unmet need," Amy Schacterle, Sage's senior vice president of research and development strategy, recently told CBS News Boston.
-Louisa Moller contributed to this report.