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 [1], 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 [2] 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 [3] from Wyeth
Related Articles:
Wyeth's Pristiq shows benefits in clinical trial. Report [4]
FDA issues approvable letter for Pristiq. Report [1]
Wyeth expects provisional OK for Pristiq. Report [5]
Links:
[1] http://www.fiercebiotech.com/story/fda-approves-pristiq-for-depression/2007-01-24
[2] http://www.fiercebiotech.com/special-reports/12-wyeth-top-15-r-d-budgets
[3] http://www.fiercebiotech.com/press-releases/new-phase-3-data-showed-pristiq-significantly-reduced-symptoms-major-depressive-disor
[4] http://www.fiercebiotech.com/story/wyeths-pristiq-shows-benefits-clinical-trial/2007-10-15
[5] http://www.fiercebiotech.com/story/wyeth-expects-provisional-ok-for-pristiq/2007-01-22