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Pristiq (desvenlafaxine succinate sustained-release) fails again in second phase III trial for depression- Pfizer

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Last updated:23rd Dec 2015
Published:23rd Dec 2015
Source: Pharmawand

Pfizer announced the top line results from a Phase III study which evaluated the efficacy, safety, and tolerability of Pristiq (desvenlafaxine succinate sustained-release) 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. Desvenlafaxine did not demonstrate superior efficacy compared to placebo in either study. Efficacy results indicate that both desvenlafaxine succinate sustained-release formulation low dose exposure and high dose exposure treatment arms 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 pediatric MDD safety studies and the studies of desvenlafaxine succinate sustained-release formulation-treated adults with MDD. This is the second of two Phase III placebo controlled studies conducted as part of an FDA post-marketing commitment under the Pediatric Research Equity Act (PREA).

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