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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

ridone palmitate doses are expressed as mg equivalent (eq.) of paliperidone, where 156 mg of paliperidone palmitate is equivalent to 100 mg of paliperidone. (b) Non-inferiority trials aim to show that a new treatment is not clinically less effective than a standard treatment by more than a pre-specified margin. (c) Positive and Negative Syndrome Scale (PANSS) is a standard rating scale used in trials to assess the severity of symptoms. The scale consists of 30 items, which are assessed from absent to extreme, and these are divided into both positive and negative symptoms. (1) Marder SR, Kramer M, Ford L, Eerdekens E, Lim P, Eerdekens M, Lowy A. Efficacy and safety of paliperidone extended-release tablets: results of a 6-week, randomized, placebo-controlled study. Biol Psychiatry. 2007 Dec 15;62(12):1363-70. (2) Davidson M, et al. Schizophr Res. 2007; 93(1-3):117-130. (3) Kane J, et al. Schizophr Res 2007; 90 (1-3):147-161. (4) Royal College of Psychiatrists website: http://www.rcpsych.ac.uk/default.aspx?page=1643 Accessed April 14, 2008. (5) American Psychiatric Association. Let's talk facts about schizophrenia. Available at: http://healthyminds.org/factsheets/LTF-Schizophrenia.pdf Accessed April 1, 2008.


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SOURCE Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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