Pfizer’s Pristiq SR fails endpoints in pediatric study for MDD
US pharma giant Pfizer (NYSE: PFE) has released disappointing top line results from a Phase III study which evaluated the efficacy, safety, and tolerability of Pristiq (desvenlafaxine succinate sustained-release formulation) in pediatric patients aged seven to 17 with major depressive disorder (MDD).
The study did not meet its primary objective to demonstrate superior efficacy of desvenlafaxine succinate sustained-release formulation compared to placebo. This is the first completed study of four Phase III pediatric trials being conducted as part of a Food and Drug Administration post-marketing commitment under the Pediatric Research Equity Act (PREA).
Study details
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