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New Study Results Provide Additional Data about Short- and,Long-Term Use of Desvenlafaxine Succinate in the Treatment of,Adults with Major Depressive Disorder

ent in the double-blind study was depression, reported by 4 percent of patients who took desvenlafaxine succinate and 8 percent of placebo patients. The most frequent adverse events with desvenlafaxine succinate in the double-blind phase included headache, nausea, dizziness, asthenia, abnormal dreams and sweating.

The double-blind study population included 375 adults, 18 to 75 years old, with a primary diagnosis of MDD who participated in an initial 12-week, open- label study of desvenlafaxine succinate at doses ranging from 200 to 400 mg/day (desvenlafaxine succinate group, n=190; placebo group, n=185). The primary efficacy endpoint in the double-blind phase of the study was time until relapse, defined by a HAM-D17 score greater than or equal to 16 at any visit; Clinical Global Impressions Scale -- Improvement score greater than or equal to 6 at any visit; or discontinuation due to unsatisfactory response. The study also assessed the response and remission of desvenlafaxine succinate vs. placebo as a secondary objective.

Poster NR344: Ferguson J, et al. A 12-Month, Open-Label Evaluation of Long-Term Safety and Efficacy of Desvenlafaxine Succinate in Outpatients with Major Depressive Disorder

The results are from a Phase 3, multicenter, open-label, flexible-dose study. This study included 104 adults, 18 to 75 years old, with a primary diagnosis of MDD who took doses of desvenlafaxine succinate ranging from 200 to 400 mg/day over a 12-month period. The primary objective was to evaluate the long-term safety of desvenlafaxine succinate as determined by monitoring a variety of indices, including adverse events, patient discontinuation due to adverse events, electrocardiograms, vital signs and the results of laboratory tests. The secondary objective was to evaluate the efficacy of desvenlafaxine succinate by using mean HAM-D17 total scores.

Study findings showed that the most frequent treatment-emergent adverse events were nausea and headache.
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