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Pfizer Announces Top-Line Efficacy Results From A Phase 4 Study Of PRISTIQ® (desvenlafaxine) For The Treatment Of Major Depressive Disorder (MDD) In Adults


Pfizer (NYSE: PFE) announced today that a Phase 4 study evaluating the efficacy of PRISTIQ® (desvenlafaxine) Extended Release Tablets met its primary endpoint. The study supports the efficacy of 50 mg/day and 100 mg/day doses of PRISTIQ compared with placebo over eight weeks of treatment in adult patients with major depressive disorder (MDD) as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score.1

In this study, the most common treatment-emergent adverse events observed were consistent with the known safety and tolerability profile of PRISTIQ.1

"These positive top-line results add to the growing body of evidence that supports PRISTIQ as a treatment option for adults with major depressive disorder," said Steven J. Romano, M.D., senior vice president, head of Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc. “We know how challenging it can be to treat and manage major depressive disorder. We continue to study PRISTIQ in order to provide clinicians with more information that can better guide their treatment decisions for MDD patients.”

The Phase 4 study was designed as a multi-center, randomized, double-blind, placebo-controlled, eight-week, parallel group study in adult patients with MDD.1 The primary efficacy endpoint was the change from baseline in HAM-D17 total score at week eight.1 The HAM-D17 is a validated assessment tool used to rate the severity of a patient's major depressive symptoms.2 The study enrolled 924 patients who were randomized in a 1:1:1 ratio to one of the following treatment arms: PRISTIQ 50 mg/day, PRISTIQ 100 mg/day or placebo.1

Results from this PRISTIQ Phase 4 study will be submitted for presentation at upcoming scientific congresses and for publication in a peer-reviewed medical journal.

About Major Depressive Disorder (MDD)

An estimated 33 to 35 million U.S. adults are likely to experience major depression at some point during their lifetime.3 The criteria for MDD include having five or more of the symptoms of depression listed below during the same two-week period and representing a change from previous functioning. Depressed mood or diminished interest or pleasure must be among the depression symptoms reported from the following list: depressed mood; diminished interest or pleasure; significant weight loss or change in appetite; insomnia/hypersomnia; psychomotor agitation; fatigue or loss of energy; feelings of worthlessness or excessive/inappropriate guilt; difficulty concentrating; and recurrent thoughts of death.4

About PRISTIQ® (desvenlafaxine)

PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is a prescription medication that was approved by the U.S. Food and Drug Administration (FDA) in 2008 for the treatment of MDD in adults.5 The recommended dose for PRISTIQ is 50 mg once daily, with or without food. In clinical studies, doses of 50-400 mg/day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg/day and adverse events and discontinuations were more frequent at higher doses.5

Posted-In: News FDA


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