Wyeth Pharmaceuticals announced that the results of two clinical Phase III trials of Pristiq (desvenlafaxine) showed that patients experienced a statistically significant reduction in their symptoms of major depression.
Adult patients who received a 50 mg/day dosage for the treatment of major depressive disorder experienced a significant change from baseline scores on the 17-item Hamilton Depression Rating Scale over 8 weeks of observation as opposed to those taking a placebo. The two randomized, double-blind, placebo-controlled studies consisted of 483 patients in the non-U.S study and 447 patients in the U.S. study. Results of both studies have been submitted to the FDA as part of its complete response to the FDA approvable letter received in January 2007. It is expected that the FDA will take action on pristiq in the first quarter of 2008.
"These findings show that PRISTIQ has the potential to reduce symptoms of MDD at doses as low as 50 mg once daily," says Philip Ninan, M.D., Vice President, Neuroscience, Global Medical Affairs. "The response rates of patients in the 50 mg/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 50 mg/day dose groups were not titrated from a lower dose when initiating therapy."
"Major depressive disorder is a chronic and disabling disease that can cause significant distress and impair an individual's daily functioning," says Michael Liebowitz, M.D., lead author of the presentation and a professor of clinical psychiatry. "Unfortunately, research and clinical practice suggest that a large percentage of patients with major depression do not respond to initial antidepressant therapy, leaving these patients still struggling with symptoms of depression. Clearly, there is a need for additional treatment options."
[Source: PRNewsWire]
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