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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

Results of Two Trials Identify Potential Initiation Dosing Regimen

TITUSVILLE, N.J., Dec. 10 /PRNewswire/ -- Paliperidone palmitate, an investigational long-acting therapy (LAT) demonstrated statistically significant symptom control compared with placebo according to the results of a 13-week study presented today (1). Statistical significance was evidenced at all doses tested (25, 100, and 150 mg equivalent [eq.a]), when given every 4 weeks with a 150 mg eq. initiation dose. A separate 53-week non-inferiority trial(b) evaluating paliperidone palmitate using only a 50 mg eq. initiation dose, and subsequent doses of 25, 50, 75, and 100 mg eq., showed that while paliperidone palmitate reduced symptoms, non-inferiority relative to risperidone LAT was not demonstrated. Safety findings in both trials were similar to those from previously published studies of paliperidone extended-release (ER) tablets in the treatment of schizophrenia (2,3). Based on these results, an additional phase III study is being conducted to further assess the higher initiation dosing regimen of paliperidone palmitate 150 mg eq. followed by a second injection of 100 mg eq. with subsequent injections every four weeks.

Paliperidone palmitate, an investigational LAT, is a formulation of the oral antipsychotic paliperidone ER, used for the acute and maintenance treatment of schizophrenia. Because of the delivery systems used, LAT formulations may produce more consistent levels of the drug in the blood and provide healthcare professionals with reassurance that patients are receiving their medication as scheduled. The two studies add more information to the body of evidence for paliperidone palmitate in the treatment of schizophrenia.

In the 13-week trial, patients were randomly assigned to receive either paliperidone palmitate 25, 100 or 150 mg eq. injection or placebo. On day 1, all patients randomly assigned to any of the paliperi
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SOURCE Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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