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Phase III Study Demonstrates INVEGA(R) SUSTENNA(TM) (paliperidone palmitate) Statistically Similar to RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Injection
Date:12/10/2009

A was non-inferior to RISPERDAL CONSTA in the treatment of schizophrenia in this trial, which validates that these are both good options," said George Simpson, M.D., professor of research at Keck School of Medicine, University of Southern California and clinical investigator for the INVEGA SUSTENNA program. "The differences between the two products, such as the shorter or longer dosing interval or the need for oral supplementation, provide options for physicians to decide what will work best for an individual patient."

About the Study

The 13-week, randomized, double-blind, double-dummy trial included 1220 adults with a diagnosis of schizophrenia and a PANSS total score of 60 to 120. Participants were randomly assigned to receive INVEGA SUSTENNA (IS) plus oral placebo or RISPERDAL CONSTA (RC) plus oral risperidone for the first three weeks.

Patients assigned to IS received an initiation dosing regimen of 234* mg on day 1 and 156 mg on day 8, followed by once-monthly dosing on day 36 (78 mg or 156 mg) and day 64 (78 mg, 156 mg, or 234 mg). Additional placebo injections were administered to match RC dosing. Patients assigned to RC received their first injection on day 8, followed by biweekly injections on day 22, 36, 50, 64 and 78. This was supplemented with placebo injections to match IS dosing. The 25 mg starting dose of RC could have been increased up to 37.5 mg starting on day 36 and up to 50 mg on day 64. Patients on RC received mandatory oral risperidone supplementation from days 1 to 28. Oral supplementation was optional with subsequent dose increases.

The primary endpoint of the trial was the change in the PANSS total score versus baseline. Non-inferiority would be concluded by calculation using a 95% confidence interval (CI) based on a pre-specified change in total PANSS score. Secondary efficacy measures included change from baseline for Clinical Global Impression-Severity (CGI-S) and Personal and Social Pe
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SOURCE Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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