By PPN Staff
The FDA approved zuranolone (Zurzuvae, Sage Therapeutics/Biogen), the first oral medication indicated for adults with postpartum depression (PPD).
The drug’s approval was based on data from two multicenter, randomized, double-blind, placebo-controlled trials in women with PPD whose symptoms began in the third trimester or within four weeks of delivery. In the SKYLARK study, participants received 50 mg of zuranolone or a placebo daily for 14 days. In the ROBIN study,