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Phase 3 Data Demonstrate Efficacy and Tolerability of Paliperidone Palmitate, an Investigational Long-Acting Therapy for the Treatment of Schizophrenia
Date:12/10/2008

AEs among the reported psychiatric disorders were insomnia (both groups 15%), psychotic disorder (PP+Pbo 14%; RIS+RIS 12%) schizophrenia (PP+Pbo 12%; RIS+RIS 9%) and anxiety (PP+Pbo 10%; RIS+RIS 15%). Adverse events leading to discontinuation occurred in 7% of PP+Pbo patients and 6% of LAT RIS+RIS patients. Based on these results, an additional phase III study is being conducted to further assess the dosing regimen of paliperidone palmitate 150 mg eq. followed by a second injection of 100 mg eq. with subsequent injections every four weeks, compared with risperidone LAT.

"These findings will help us determine the best dosing strategy for paliperidone palmitate in the treatment of schizophrenia," said lead author, Professor Wolfgang Fleischhacker, Dept of Psychiatry and Psychotherapy, Medical University Innsbruck*. "This could provide a valuable option for healthcare professionals to help people who are struggling with this illness."

INVEGA(R) (paliperidone) Extended-Release Tablets, the oral formulation of paliperidone, was first approved in 2006 in the U.S. for the acute treatment of schizophrenia. In March 2007, INVEGA was approved for the maintenance treatment of schizophrenia in the U.S. It was also approved for the treatment of schizophrenia in the European Union in June 2007.

Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness(4). An estimated 2.4 million Americans have schizophrenia, with men and women affected equally(5). The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions, and social withdrawal), as well by disorganized thinking, speech and behavior.

The study was sponsored by Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD). Once approved, Janssen, Division of Ortho-McNeil-Janssen Pharmace
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SOURCE Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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