Pfizer announced that data from a clinical study showed similar sexual function in adults with major depressive disorder (MDD) treated with Pristiq (desvenlafaxine) 50mg and 100mg extended-release tablets daily vs. placebo. Results of this study are published in the Journal of Clinical Psychiatry.

This Phase 4 postmarketing study was conducted as part of a Food and Drug Administration (FDA) requirement to evaluate sexual dysfunction, a common issue with patients taking antidepressants.

The multicenter, randomized, double-blind, placebo-controlled study enrolled 924 adults aged ≥18 years. They were randomized to Pristiq 50mg daily, Pristiq 100mg daily, or placebo. The primary endpoint of the study was the change from baseline in the Hamilton Rating Scale for Depression (HAM-D17) total score at Week 8. The results demonstrated a statistically significant improvement among patients treated with Pristiq vs. placebo in MDD symptoms over eight weeks.

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The secondary endpoint assessed sexual dysfunction by the Arizona Sexual Experiences Scale (ASEX). Adults with MDD with baseline sexual activity and at least one post-baseline assessment, effects on ASEX total and item scores were similar for both Pristiq groups and placebo. Rates of sexual dysfunction were also similar between the Pristiq 50mg daily, Pristiq 100mg daily, and placebo at baseline (56%, 52%, 54%, respectively) and at Week 8 (49%, 47%, 45%, respectively).

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