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FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
Date:7/31/2009

ia Research Program at the University of Cincinnati College of Medicine. "The approval of once-monthly INVEGA SUSTENNA will provide healthcare professionals with a treatment option that is, at the same time, a definitive monitoring tool for uninterrupted medication compliance, which may help optimize clinical outcomes in schizophrenia."

The approval is based on four acute symptom control studies and a longer-term maintenance study that compared INVEGA SUSTENNA to placebo. INVEGA SUSTENNA was superior to placebo in improving positive and negative syndrome scale (PANSS) total scores in the acute treatment trials and significantly delayed time to relapse vs. placebo in the longer-term maintenance study.

The most recent acute symptom control study was a multi-center, randomized, placebo-controlled, double-blind, parallel-group study (n=636). All patients received a dose of 234 mg on Day 1 in the deltoid muscle. From Day 8 and monthly thereafter, patients were assigned to one of three fixed doses of INVEGA SUSTENNA for a period of 13 weeks. The primary endpoint of this study was the change in total PANSS score from baseline to endpoint. Each of the three additional acute treatment studies involving INVEGA SUSTENNA met its primary endpoint of significantly improving PANSS scores relative to placebo.

The efficacy of INVEGA SUSTENNA in maintaining symptomatic control in schizophrenia was evaluated in a multicenter, randomized, double-blind, placebo-controlled, parallel-group study (n=410). Time-to-first relapse - the primary endpoint of the study - was significantly longer for patients receiving INVEGA SUSTENNA compared with placebo-treated patients (P<0.0001). During the double-blind phase of the study, fewer patients treated with INVEGA SUSTENNA experienced a relapse (10% [n=15/156]) compared with those in the placebo group (34% [n=53/156]).

Because maintenance of efficacy was demonst
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SOURCE Janssen
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