NEW YORK (Reuters Health) - An investigational schizophrenia drug called bifeprunox appears to have fewer worrisome side effects than current agents used to treat schizophrenia -- a disease marked by distorted thinking and hallucinations.
That's according to safety data derived from previously reported mid- and late-stage clinical studies of bifeprunox, which were presented Friday at the International Congress on Schizophrenia Research in Colorado Springs.
"It looks like bifeprunox is going to be a very tolerable drug," Dr. Herbert Y. Meltzer said in a telephone interview with Reuters Health. Meltzer is director of the division of psychopharmacology at Vanderbilt University, Nashville, Tennessee and has been involved in bifeprunox studies.
"What I can glean from the individual studies and the composite data is that, on average, there isn't any significant weight gain, increase in lipids or signs of (blood sugar) dysregulation," said Meltzer.
In some studies, after switching to bifeprunox, some patients actually lost weight and improved their lipid profile.
Side effects with currently available "antipsychotics," such as weight gain and an increase in cholesterol levels, are a major problem for people with schizophrenia who need to take drugs for all their lives.
Bifeprunox is being developed jointly by Solvay Pharmaceuticals Inc., Wyeth Pharmaceuticals, and Lundbeck A/S of Denmark. Solvay filed a new drug application on bifeprunox with the US Food and Drug Administration in October 2006.
In previously reported efficacy studies, bifeprunox improved symptoms in patients with acute flares of schizophrenia but showed a smaller average effect than did two currently available schizophrenia drugs.
Bifeprunox also helped prevent deterioration in schizophrenia patients whose symptoms were already under control.
"If approved, bifeprunox may be an important alternative for treating adult patients with schizophrenia over the long term," Meltzer said in a statement, "particularly because of our concerns about the high prevalence of metabolic syndrome in this patient population."
