Pristiq (desvenlafaxine succinate sustained-release ) fails Phase III trial in children for depression-Pfizer

Pfizer Inc announced the 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 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. This is the first completed study of four Phase III pediatric trials being conducted as part of an FDA post-marketing commitment under the Pediatric Research Equity Act (PREA).

There were no new safety signals identified. Adverse events occurring after the start of treatment in the desvenlafaxine succinate sustained-release formulation group were generally consistent with those observed in both the Phase IIa pediatric MDD safety studies and the studies of desvenlafaxine succinate sustained-release formulation-treated adults with MDD. Full results from the study will be submitted for publication.