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Safety Analyses of Clinical Data for Bifeprunox in Patients with,Schizophrenia Showed a Favorable Weight and Lipid Profile, Similar,to Placebo

in, similar to placebo. * Bifeprunox patients experienced decreases in body weight, body mass index (BMI) and prolactin and had an extrapyramidal side effects profile similar to placebo. -- Weight, BMI and lipids were assessed in patients with acute exacerbations of schizophrenia in an analysis of another Phase 3, six-week, randomized, double-blind, placebo-controlled active- referenced study: * Weight decreases and minor reductions in BMI were observed in patients who received bifeprunox. * Cholesterol and TG levels improved in patients who received bifeprunox. Efficacy and Metabolic Effects -- A pooled analysis examined efficacy and metabolic effects of bifeprunox from one six-month, randomized, double-blind, placebo-controlled study in stable adult patients and four six-week, randomized, double-blind, placebo-controlled active-referenced studies in patients with acute exacerbations of schizophrenia: * Evaluations included time to deterioration in a six-month study, change in Positive and Negative Syndrome Scale (PANSS) total score in six-week studies, and body weight and lipids in all studies. * In patients who received bifeprunox, weight decreases and improvements in lipid parameters were observed along with significant differences in primary efficacy measurements versus placebo. Pharmacokinetic Analysis -- This abstract reported a pooled analysis of 21 clinical pharmacology studies that included pharmacokinetic profiles after single and multiple doses: * Bifeprunox was absorbed within two hours at all dose levels after oral administration. * Food had no relevant effect on the pharmacokinetics of bifeprunox.

In these analyses, the most common side effects reported with bifeprunox (incidence of gre
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