Wyeth is revealing more Pristiq data today from two Phase III clinical studies of Pristiq. Earlier this year, the FDA issued an approvable letter for Pristiq, delaying the launch of the drug for major depressive disorder. The data showed that patients who received a 50 mg/day dose of the drug for MDD experienced a statistically significant reduction in the symptoms of major depression compared to placebo.
Wyeth, which has had several promising drugs fizzle out this year, says the data has been submitted to the FDA. The agency is expected to make a decision on the drug in the first quarter of 2008.
- see this release from Wyeth