Pfizer’s Pristiq Phase IV trial shows low potential for sexual dysfunction in adults with MDD

Carried out in agreement to a post-marketing requirement by the US Food and Drug Administration (FDA), the trial showed comparable sexual function in these adults treated daily with Pristiq extended release tablets 50mg and 100mg doses versus placebo.

The trial’s primary end point showed a statistically significant improvement among patients treated with Pristiq compared to placebo in symptoms of MDD as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score over an eight-week period.

Secondary end point of the trial was sexual dysfunction and was measured using the Arizona Sexual Experiences Scale (ASEX), a validated and reliable patient rated sexual function scale in the US.

University of Virginia Health System interim chair, Department of Psychiatry and Neurobehavioral Sciences and lead investigator of the study, Dr Anita Clayton said: "Sexual dysfunction is a common concern for patients treated with antidepressants.

"The low potential for sexual dysfunction with desvenlafaxine is encouraging, and physicians and patients would benefit from further study."

The multi-center, randomized, double- blind placebo-controlled trial enrolled a total of 924 patients, 18-years or older, with a baseline HAM-D17 score of =20.

In the trial, patients were randomly assigned to Pristiq 50mg/day, Pristiq 100mg/day or placebo in a 1:1:1 ratio over an eight-week period.

Pfizer Global Established Pharma global clinical and medical affairs head Dr Salomon Azoulay said: "The treatment and management of MDD in adults can be both complex and challenging for physicians and patients.

"As a science-based company, 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."

Image: Desvenlafaxine succinate 50mg Tablets (Pristiq brand). Photo: courtesy of Tom Varco.