An investigative drug for treating postpartum depression is one step closer to being the first federally approved pill for the condition that affects 1 in 8 mothers, The Boston Globe reported Feb. 6.
In a news release, Sage Therapeutics said the FDA accepted its new drug application filing for zuranolone — which is co-sponsored by Biogen — to treat major depressive disorder and postpartum depression. The regulatory agency deemed the application with priority review and set the decision date for Aug. 5.
Zuranolone's application seeks approval as a 14-day, rapid-acting pill taken once a day in adults with major depressive disorder and postpartum depression, according to Sage Therapeutics.
The company already markets and sells the only drug approved for postpartum depression, but it requires 60 hours of hospital-administered infusions and costs $34,000, according to the Globe. Postpartum depression affects anywhere from 6.5 percent to 20 percent of women, according to the National Library of Medicine. Sage Therapeutics said 1 in 8 mothers — or 500,000 people in the U.S. annually — are estimated to have had postpartum depression.