INVEGA(TM) Significantly Reduced Symptoms of Schizophrenia Compared to SEROQUEL(R) in Acutely Ill, Hospitalize... (monotherapy phase (primaryendpoint) foll...)

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INVEGA(TM) Significantly Reduced Symptoms of Schizophrenia Compared to SEROQUEL(R) in Acutely Ill, Hospitalized Patients

Date:10/13/2007

monotherapy phase (primary endpoint) followed by a four-week additive therapy phase (secondary endpoint). During the four-week phase, patients could be prescribed additional psychotropic therapy as clinically indicated to manage psychiatric symptoms.

Recent trials in hospitalized patients have suggested the need for higher doses in the treatment of acute patients(2). This study examined the effects of recommended labeled doses while taking into account common clinical practice for this patient population. INVEGA was initiated at the recommended starting dose of 6mg/day (days one to three) increasing to 9 mg/day on day four. As these patients were acutely ill, there was an option to increase the dose to 12 mg/day on day eight. SEROQUEL was titrated to 600 mg/day by day five with an option to increase the dose to 800 mg/day on day eight. Because this study enrolled severely ill patients with recent onset of symptoms, patients were more likely to require doses near the upper end of the recommended ranges to control their symptoms. The average doses during the monotherapy phase were 10.4 mg/day for INVEGA and 690.9 mg/day for SEROQUEL.

The primary efficacy endpoint was total change in PANSS score from baseline to the end of the monotherapy phase (day 14). The average PANSS score at baseline was 102.8 (plus or minus 13.1) for the INVEGA group, 101.6 (plus or minus 13.5) for the SEROQUEL group, and 103.8 (plus or minus 15.7) for the placebo group. At the end of the monotherapy phase (day 14), the change in the total score from baseline was: -23.4 (1.8) for INVEGA, - 17.1(1.8) for SEROQUEL and -15.0 (2.2) for placebo, with INVEGA showing a significant reduction in symptoms over both SEROQUEL (p < less than > 0.001) and placebo (p < less than > 0.001).

In a separate analysis, INVEGA(TM) also produced a statistically significant improvement in the reduction in the individual symptom domains of the PANSS, which includes positive symptoms, negative symptoms,
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SOURCE Janssen, L.P. and Johnson & Johnson
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