New Phase 3 Data Showed PRISTIQ Significantly Reduced Symptoms Of Major Depressive Disorder Versus Placebo

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"These findings express that PRISTIQ focused the probable to decrease symptom of MDD at dose in place of insufficient as 50 mg once all day," say Philip Ninan, M.D., Vice President, Neuroscience, Global Medical Affairs. "The rejoinder rates of patients bounded beside the 50 mg/day dose society be alike to the rates see at person in charge doses. We are also pressed by the tolerability profile shown in the two studies presented at this league. Notably, area in the 50 mg/day dose groups were not titrated from a mock dose when initiate analysis." Wyeth submit in August 2007 the grades of the two studies to the U.S. Food and Drug Administration (FDA) as segment of its categorical response to the FDA approvable dispatch it received in January 2007 for PRISTIQ for the psychoanalysis of MDD. FDA commotion next to the status be looked-for during the primary quarter of 2008. The clinical notes for PRISTIQ presented at the meeting epitomize lone a plateful of the data from the ongoing clinical initiation of PRISTIQ and are not necessarily demonstrating of the totality of data and other facts that may affect further development, regulatory foresight and/or commercialization of PRISTIQ.

More About the Studies Poster 145: Liebowitz M., et al. Evaluation of the Efficacy and Safety of Fixed Doses of Desvenlafaxine Succinate at 50 mg and 100 mg in Outpatients with Major Depressive Disorder in 2 Placebo-Controlled Trials Data presented are from two identically designed multicenter, randomized, double-blind, placebo-controlled, eight-week studies, one conduct al fresco of the United States involving 483 fully fledged patients, and one in the U.S. with 447 adult patients. Primary efficacy in both trial be inexorable plinth on move from baseline evaluation on the 17-item Hamilton Depression Rating Scale (HAM-D17). Patients in both desvenlafaxine groups started treatment at 50 mg/day. For the 100 mg/day group, the dose was increased to 100 mg/day on the eighth daylight of the workroom.

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