Data Presented on Antipsychotic Showing Good Weight and Lipid Profile

Wyeth Pharmaceuticals, Solvay Pharmaceuticals and Lundbeck have presented results of pooled analyses on bifeprunox. The data suggest that bifeprunox, an investigational treatment for schizophrenia, was associated with a favorable weight and lipid profile similar to that of placebo.

The analyses are based on further evaluation of clinical studies presented last year, which illustrated that, in a six-month trial, bifeprunox maintained stability in patients with stable schizophrenia versus placebo. In six-week trials, bifeprunox improved symptoms in patients with acute exacerbations of schizophrenia but showed a smaller mean effect than did active references versus placebo.

"Data from Phase II and Phase III trials suggest that, if approved, bifeprunox may be an important treatment option for stable patients with schizophrenia -- particularly because of our concerns about the high prevalence of metabolic syndrome in this patient population," Herbert Meltzer, professor of psychiatry and director of the Division of Psychopharmacology at Vanderbilt University Medical Center, said.

In analyses of data from Phase III, six-week, randomized, double-blind, placebo-controlled active-referenced studies, bifeprunox had favorable effects on total cholesterol, triglycerides and LDL, similar to placebo. Bifeprunox patients experienced decreases in body weight, body mass index and prolactin and had extrapyramidal side effects profiles similar to placebo.

Another 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 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.

Wyeth and Solvay submitted a new drug application for bifeprunox in October 2006.