Zurzuvae

The approval was based on data from the NEST program, which included 2 randomized, placebo-controlled, double-blind studies evaluating Zurzuvae in adult women with PPD: SKYLARK (ClinicalTrials.gov Identifier: NCT04442503) and ROBIN (ClinicalTrials.gov Identifier: NCT02978326). The primary endpoint for both studies was the change from baseline in depressive symptoms as measured by the 17-item Hamilton Anxiety Rating Scale (HAMD-17) total score at day 15.

In SKYLARK, patients received Zurzuvae 50mg (n=98) or placebo (n=97). In ROBIN, patients received another zuranolone capsule approximately equivalent to 40mg of Zurzuvae (n=76) or placebo (n=74). Treatment was administered once daily in the evening with fat-containing food for 14 days. Dosage reduction was allowed based on tolerability. Patients were followed for a minimum of 4 weeks.

Findings showed that treatment with Zurzuvae led to a statistically significant improvement in depressive symptoms compared with placebo as measured by HAMD-17 total score. The placebo-subtracted difference was -4.0 (95% CI, -6.3, -1.7) in SKYLARK and -4.2 (95% CI, -6.9, -1.5) in ROBIN. This effect was reported to be maintained 4 weeks after the last dose of Zurzuvae (day 42).

The effect of nighttime administration of Zurzuvae on next morning driving performance was evaluated in 2 randomized, double-blind, placebo-, and active-controlled 4-way crossover studies. Findings showed that Zurzuvae did cause driving impairment due to central nervous system depressant effects.