This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryPhase III pivotal study of a long-acting injectable depot version of risperidone shows "significantly greater improvement" on the Positive and Negative Symptom Scale for patients receiving the antipsychotic than those receiving placebo, Janssen's Marielle Eerdekens reports in a May 2 conference call. In the U.S. trial, which enrolled 400 schizophrenia patients, a decrease of more than 20% on the PANNS total score was seen in 47% and 48% of 25 and 50 mg risperidone patients, respectively, vs. 17% of placebo patients. The drop-out rate due to lack of efficacy was 22%, 16% and 12% for patients receiving 25, 50 and 75 mg risperidone, vs. 30% for placebo. The most frequently reported side effects were headache, agitation, insomnia and anxiety. The company plans to submit an NDA for the injectable agent shortly
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