The endpoint of the parallel group study is a change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score at the eighth week.
The multi-center study conducted in adults with MDD has established efficacy of 50mg/day and 100mg/day doses of Pristiq over eight-week treatment period compared to placebo, as calculated by the HAM-D17 total score.
Pfizer global primary care business unit, medicines development group head and senior vice president Steven Romano said positive top-line results support Pristiq as a treatment option for adults with major depressive disorder.
"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," Romano added.
A total of 924 MDD patients were randomized in the double-blind study with either Pristiq 50mg/day, Pristiq 100mg/day or placebo in 1:1:1 ratio.
Commonly observed adverse events were similar to identified safety and tolerability profile of Pristiq, a selective serotonin and norepinephrine reuptake inhibitor.