A pill that is being developed to treatshows promise for new parents suffering from the condition, according to newly published clinical trial data.
The studiopublished Wednesday in The American Journal of Psychiatry, found the drug, zuranolone, from manufacturers 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 received either 50 milligrams per day of zuranolone or 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 side effects reported with the drug were somnolence (drowsiness), dizziness, and sedation. “No loss of consciousness, withdrawal symptoms, or increased suicidal ideation or behavior was observed,” the study authors wrote.
Zuranolone is the design to be taken as a once a day pill for 14 days. It has not yet been 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 opportunity for some of those assessed 1 in 8 women who experience symptoms of postpartum depression, which can include sadness, anxiety, irritability, loss of appetite and even self-harm.
At the moment there is onlyspecially designed to treat postpartum depression: Zulresso, developed by Sage. Launched in 2019, this drug is given intravenously to patients over 60 hours in a healthcare setting.
A 14-day, fast-acting daily pill option, if approved, could make the treatment more accessible.
“Obviously, we think zuranolone will be available to many, many more patients, and we’re excited about that, to really fill that unmet need,” Amy Schacterle, Sage’s senior vice president of research and development strategy, said recently..
-Louisa Møller contributed to this report.