Forest Laboratories, Inc. (FRX) and Pierre Fabre Medicament announced positive top-line results in a Phase III clinical trial of levomilnacipran, an investigational agent for the treatment of adults with major depressive disorder, or MDD.
Treatment with levomilnacipran significantly reduced depression symptoms in patients with MDD versus placebo, as early as week one and at each subsequent visit as measured by the Montgomery-Asberg Depression Rating Scale-Clinician Rated. Levomilnacipran was generally well-tolerated in this study. The premature discontinuation rates were 25 percent for levomilnacipran and 21 percent for placebo. The most common adverse events observed in the levomilnacipran group were nausea, dizziness and constipation.
Results from an additional placebo-controlled Phase III fixed-dose study are expected in Spring 2012.
by RTT Staff Writer
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