The FINANCIAL — Pfizer Inc announced the top line results from a Phase 3 study which evaluated the efficacy, safety, and tolerability of Pristiq (desvenlafaxine succinate sustained-release formulation) in pediatric patients ages 7 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, according to Pfizer.
This is the first completed study of four Phase 3 pediatric trials being conducted as part of an FDA post-marketing commitment under the Pediatric Research Equity Act (PREA).