Top Line Results for Pristiq in Pediatric MDD Announced

Pfizer announced top line results from a Phase 3 study evaluating Pristiq (desvenlafaxine succinate sustained-release formulation) in pediatric patients ages 7–17 with Major Depressive Disorder (MDD).

The study was a randomized, double-blind, placebo-controlled Phase 3 trial which evaluated the efficacy, safety, and tolerability of desvenlafaxine succinate sustained-release formulation in 363 pediatric outpatients ages 7–17 with MDD. Patients were randomized to receive desvenlafaxine succinate sustained-release formulation low dose exposure (weight-based dosing to achieve pediatric exposures approximating exposures in adults receiving 25mg/day), desvenlafaxine succinate sustained-release formulation high dose exposure (weight-based dosing to achieve pediatric exposures approximating exposures in adults receiving 35mg/day), or placebo. The primary objective was to demonstrate superior efficacy of desvenlafaxine succinate sustained-release formulation compared to placebo.

RELATED: Cognitive Therapy and Meds Equally Effective for Major Depression

Study results showed that desvenlafaxine succinate sustained-release formulation failed to achieve its primary objective of superiority. Both low dose exposure and high dose exposure treatment groups did not show statistically significant difference over placebo. No safety concerns were identified. Detailed results will be submitted for publication.

This is the second of two Phase 3 placebo-controlled studies conducted as part of an FDA post-marketing commitment under the Pediatric Research Equity Act (PREA) that failed to demonstrate superior efficacy for desvenlafaxine compared to placebo.

Pristiq, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of MDD in adults.

For more information call (800) 438-1985 or visit Pfizer.com.

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