Wyeth Pharmaceuticals, a division of Wyeth, Solvay Pharmaceuticals, Inc. and Lundbeck A/S presented clinical study results for bifeprunox at a major medical conference this week. Bifeprunox is an investigational treatment for schizophrenia studied as a once-daily regimen. Results of these efficacy and safety studies showed that, in a six-month trial, bifeprunox maintained stability in patients with stable schizophrenia vs. 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 vs. placebo.
Additionally, bifeprunox showed a favorable weight and metabolic profile in both short- and long-term studies vs. placebo or active references. Weight gain and metabolic disturbances are common and important side effects of many antipsychotic medications, which can cause some patients with schizophrenia to stop taking their medication.
"Based on the data from Phase 2 and Phase 3 trials, including its metabolic profile, if approved, bifeprunox may be a valuable treatment option for stable patients with schizophrenia," says Daniel Casey, M.D., Professor, Psychiatry and Neurology, Oregon Health and Science University. "These are important new findings because some obstacles, including side effects associated with current treatments, can derail the optimal long-term care of patients with schizophrenia."
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