Wyeth's Pristiq cleared for adults with MDD

US drug major Wyeth says that the Food and Drug Administration has approved Pristiq (desvenlafaxine), a structurally-novel, once-daily serotonin-norepinephrine reuptake inhibitor, to treat adult patients with major depressive disorder. Wyeth expects to begin shipping the agent to wholesalers in the second quarter.

Pristiq is Wyeth's fourth new drug to receive approval in the last 12 months. The agent is approved at a once-daily 50mg dose that does not require titration, allowing physicians to start their patients at the recommended therapeutic dose, noted Wyeth.

The efficacy of Pristiq as a treatment for depression was established in four eight-week, randomized, double-blind, placebo-controlled, fixed-dose studies in adult out-patients who met the Diagnostic and Statistical Manual of Mental Disorders criteria for MDD. At the recommended dose of 50mg, the discontinuation rate due to an adverse experience for Pristiq (4.1%) was similar to the rate for placebo (3.8%).