The US FDA has approved Zurzuvae (50mg) in adults with PPD. The product is expected to be commercially available in Q4’23
The approval was based on the results from the (NEST) clinical development program incl. two studies (ROBIN) and (SKYLARK) studies evaluating Zurzuvae vs PBO in adult women with PPD. Both studies met their 1EPs & showed a significant mean reduction from baseline in the 17-item HAMD-17 total score on Day 15
The (SKYLARK) study met 2EPs with a significant reduction in depressive symptoms seen as early as Day 3 and sustained through Day 45, was well-tolerated with a consistent safety profile. The US FDA has issued a CRL for zuranolone’s NDA to treat MDD
Ref: Biogen | Image: Biogen
Related News:- Sage and Biogen Present P-III (SKYLARK) Study Results of Zuranolone for Postpartum Depression at ECNP 2022
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