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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

TITUSVILLE, N.J., Dec. 10 /PRNewswire/ -- Treatment with once-monthly INVEGA® SUSTENNA(TM) is not inferior to treatment with bi-weekly RISPERDAL® CONSTA®, according to new data from a comparative study of both treatments in patients with schizophrenia. Results of the 13-week clinical trial were released this week.

An estimated one percent of the world's population suffers from schizophrenia - a brain disorder that impairs a person's ability to think clearly, relate to others, and distinguish between reality and imagination. In the U.S., approximately 2.4 million Americans have schizophrenia, with men and women affected equally.(1) Non-adherence to medication treatment is a common problem encountered in patients with schizophrenia, which can lead to relapse (an increase in symptoms) and hospitalization.(2) Since both INVEGA SUSTENNA and RISPERDAL CONSTA are given by a healthcare professional, it offers the physician a way to monitor patient medication adherence and intervene when a patient misses a dose. Both products offer flexibility to physicians and patients, based on their dosing regimens, thereby offering an important option to those who may need it.

The objective of this study was to show that INVEGA SUSTENNA was statistically similar (non-inferior) to RISPERDAL CONSTA, as measured by the Positive and Negative Syndrome Scale (PANSS). INVEGA SUSTENNA, a once-monthly injectable atypical antipsychotic, was recently approved in the U.S. for the acute and maintenance treatment of schizophrenia in adults. RISPERDAL CONSTA, the first long-acting injectable atypical antipsychotic, was approved for the treatment of schizophrenia in adults in the U.S. in 2003, and recently was approved for use as maintenance therapy in the treatment of Bipolar I Disorder.

"Physicians need treatment options that match the needs of their patients, particularly when compliance is a significant issue. INVEGA SUSTENN
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SOURCE Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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