Pfizer's Antidepressant Pristiq May Not Harm Sexual Function
Pfizer posted favorable results from a post-marketing clinical study investigating the potential of antidepressant Pristiq to cause sexual dysfunction in patients with major depressive disorder (MDD).
Pristiq is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) approved in 2008 as a prescription drug for the treatment of MDD in adults. In response to the U.S. Food and Drug Administration’s (FDA) requirement, Pfizer conducted a post-marketing clinical study of Pristiq Extended Release Tablets 50mg and 100mg doses compared to placebo.
Dr. Salomon Azoulay, global clinical and medical affairs head of Pfizer Global Established Pharma, said, “The treatment and management of MDD in adults can be both complex and challenging for physicians and patients. …We continue to study PRISTIQ in order to provide clinicians with information that can help guide their treatment decisions and positive health outcomes for patients with MDD.”
Results from the randomized, double blind, placebo-controlled Phase 4 study showed that Pristiq achieved a statistically significant improvement in patients with MDD compared to placebo, which was the primary endpoint of the trial. Sexual dysfunction was investigated as a secondary endpoint. The company reported that sexual dysfunction was comparable between Pristiq 50 mg and 100 mg groups compared to placebo at baseline.
Dr. Anita Clayton, study lead investigator, and interim chair of the Department of Psychiatry and Neurobehavioral Sciences at the University of Virginia Health System, said, “Sexual dysfunction is a common concern for patients treated with antidepressants. This study showed that sexual function was comparable between desvenlafaxine and placebo. The low potential for sexual dysfunction with desvenlafaxine is encouraging, and physicians and patients would benefit from further study.”
The study results were published online entitled “Desvenlafaxine 50 and 100 mg/d Versus Placebo for the Treatment of Major Depressive Disorder: A Phase 4, Randomized Controlled Trial” in the Journal of Clinical Psychiatry.