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news.Pfizer has reported top line results from a Phase III trial which evaluated the efficacy, safety, and tolerability of Pristiq (desvenlafaxine succinate sustained-release formulation) in pediatric patients aged 7-17 with major depressive disorder (MDD).
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The trial did not meet its primary objective to show superior efficacy of desvenlafaxine succinate sustained-release formulation compared to placebo.
The company said that this is the first completed trial of four Phase III pediatric trials being carried out as part of an FDA post-marketing commitment under the Pediatric Research Equity Act (PREA).
A total of 340 subjects were randomized in this double-blind, placebo-controlled, fluoxetine-referenced Phase III trial.
Of the total enrolled patient population, 38.3% were children between seven and 11 years of age and 61.7% were adolescents aged 12-17 years.
The trial included three treatment arms: desvenlafaxine succinate sustained-release formulation (weight-based dosing to achieve pediatric exposures approximating exposures in adults receiving 35mg/day), fluoxetine (20mg/day) and placebo.
Pristiq is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) approved by the US Food and Drug Administration (FDA) in 2008 to treat MDD in adults.
Efficacy results show that both desvenlafaxine succinate sustained-release formulation and the positive control, fluoxetine, were not statistically significantly different from placebo.
The company said that 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 trials of desvenlafaxine succinate sustained-release formulation-treated adults with MDD.