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PRISTIQ (desvenlafaxine succinate) Indications And Clinical Use

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Indications And Clinical Use

Adults

PRISTIQ (desvenlafaxine succinate extended-release tablets) is indicated for the symptomatic relief of major depressive disorder.

The short-term efficacy of PRISTIQ has been demonstrated in placebo-controlled trials of up to 8 weeks.

The efficacy of PRISTIQ in maintaining an antidepressant response for up to 26 weeks, following response during 20 weeks of acute, open-label treatment, was demonstrated in a placebo-controlled trial.

Pediatrics (< 18 years of age)

Based on the data submitted and reviewed by Health Canada, the safety and efficacy of PRISTIQ in pediatric patients have not been established; therefore, Health Canada has not authorized an indication for pediatric use.

Two placebo controlled studies in 587 pediatric patients 7 to 17 years of age with MDD failed to demonstrate efficacy; neither short term, placebo-controlled study demonstrated statistically or clinically significant differences between PRISTIQ and placebo (see WARNINGS AND PRECAUTIONS, Potential Association with Behavioural and Emotional Changes, Including Self-Harm; also Special Populations, Pediatrics; ADVERSE REACTIONS, Pediatrics; ACTION AND CLINICAL PHARMACOLOGY, Pediatrics). 

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