FDA Approves Zurzuvae (zuranolone) for Postpartum Depression in Adults

Zurzuvae is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator.

Zurzuvae is indicated for the treatment of postpartum depression (PPD) in adults.

Administer with fat-containing food. Recommended dosage is 50 mg orally once daily in the evening for 14 days. Dosage may be reduced to 40 mg once daily if CNS depressant effects occur. Zurzuvae can be used alone or as an adjunct to oral antidepressant therapy. Severe hepatic impairment: 30 mg once daily for 14 days. Moderate or severe renal impairment (eGFR <60 mL/min/1.73 m2): 30 mg once daily for 14 days. Avoid concomitant use with CYP3A4 inducers; reduce to 30 mg once daily with strong CYP3A4 inhibitors. If a dose is missed, take the next dose at the regular time the following evening; do not take extra capsules.

Efficacy was demonstrated in two randomized, placebo-controlled, double-blind, multicenter studies (Study 1, NCT04442503 and Study 2, NCT02978326) in women with PPD meeting DSM-5 criteria for a major depressive episode with onset in the third trimester or within 4 weeks of delivery. Concomitant stable oral antidepressants were allowed. Primary endpoint was change from baseline in HAMD-17 total score at Day 15. In both studies, Zurzuvae showed statistically significantly greater improvement vs placebo. For Study 1, key secondary endpoints included change from baseline at Days 3, 28, and 45.

Not reported in label.

Zurzuvae offers a 14-day oral treatment course for PPD, with the option to reduce dose for tolerability. It can be used alone or as an adjunct to oral antidepressant therapy. Safety and efficacy beyond 14 days have not been established.