Wyeth Reports Positive Pristiq Data
Posted on: Thursday, 13 December 2007, 15:00 CST
Wyeth Pharmaceuticals has said that data from two Phase III clinical studies has shown that adult patients who received a 50mg/day dose of Pristiq for the treatment of major depressive disorder experienced a statistically significant reduction in the symptoms of major depression compared to placebo.
In both studies, discontinuation rates due to adverse events (AEs) for Pristiq 50mg/day were similar to placebo. In the two studies, the rates of discontinuation due to AEs for placebo and Pristiq 100mg/day were 3% and 7%, respectively.
The two studies, which evaluated efficacy and safety of Pristiq for the treatment of major depressive disorder (MDD) at fixed doses of 50mg/day and 100mg/day, will be presented at a major medical meeting. This will be the first time an analysis of the 50 mg/day dose for Pristiq for the treatment of MDD is presented.
Philip Ninan, vice president, neuroscience, global medical affairs of Wyeth, said: "These findings show that Pristiq has the potential to reduce symptoms of MDD at doses as low as 50mg once daily. The response rates of patients in the 50mg/day dose groups are similar to the rates seen at higher doses. We are also encouraged by the tolerability profile shown in the two studies presented at this meeting. Notably, subjects in the 50mg/day dose groups were not titrated from a lower dose when initiating therapy."
Source: Datamonitor
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