Phase 3 study evaluating Pristiq in paediatric patients with major depressive disorder fails to meet its primary objective

Pfizer has reported the top line results from a Phase 3 study which evaluated the efficacy, safety and tolerability of Pristiq® (desvenlafaxine succinate sustained-release formulation) in paediatric patients ages 7 to 17 with Major Depressive Disorder (MDD).

The study did not meet its primary objective to demonstrate superior efficacy of Pristiq compared to placebo.

This is the first completed study of four Phase 3 paediatric trials being conducted as part of a US Food and Drug Administration (FDA) post-marketing commitment under the Paediatric Research Equity Act (PREA).

The study was a randomised, double-blind, placebo-controlled, fluoxetine-referenced study designed to evaluate the efficacy, safety, and tolerability of Pristiq in paediatric outpatients ages 7 to 17 with MDD. The patient population was comprised of children (7-11 years of age) and adolescents (12-17 years of age) and included three treatment arms: Pristiq, fluoxetine and placebo.

Full results from the Pristiq study will be submitted for publication

Efficacy results indicate that both desvenlafaxine succinate sustained-release formulation and the positive control, fluoxetine, were not statistically significantly different from placebo.

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 2a paediatric 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.