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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

done palmitate treatment groups received a 150 mg eq. injection in the deltoid muscle. On day 8 and every 4 weeks for the duration of the trial they received the randomly assigned fixed dose (25, 100 or 150 mg eq.) in the deltoid or gluteal muscle. The primary endpoint of the trial was change in PANSS(c) total score from baseline to endpoint.

The results showed that with the 150 mg eq. initiation dose, patients taking paliperidone palmitate at any of the three doses (25, 100, or 150 mg eq.) had significantly improved symptoms, based on the primary outcome parameter of change in PANSS total scores, compared to patients on placebo (p is less than or equal to 0.034). Symptoms improved with increased dosage, with those taking the 150 mg eq. dose showing the greatest improvement. Overall treatment-emergent adverse events (TEAEs) occurred at similar rates among the paliperidone palmitate (60-63%) and placebo (65%) groups. The number of patients who reported serious TEAEs was higher in the placebo group (14%) than in any of the paliperidone palmitate groups (25 mg eq. 9.4%; 100 mg eq. 13.3%; 150 mg eq. 8.0%). Common TEAEs occurring greater than or equal to 2% more frequently in the total paliperidone palmitate group compared to the placebo group were injection site pain (placebo, 3.7% vs 7.6% with paliperidone palmitate), dizziness (placebo 1.2% vs 2.5% with paliperidone palmitate), sedation (placebo 0.6% vs 2.3% with paliperidone palmitate), pain in extremity (placebo 0% vs 1.6% with paliperidone palmitate) and myalgia (placebo 0% vs 1.0% with paliperidone palmitate). The overall safety profile was similar to previously published studies of paliperidone ER in the treatment of schizophrenia(1,2).

The authors concluded that using a 150 mg eq. deltoid initiation dose followed by subsequent injections every 4 weeks of 25-150 mg eq. of paliperidone palmitate produced statistically significant symptom control as measured by the P
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SOURCE Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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