Six-month trial data show bifeprunox maintains stabilized schizophrenia significantly longer than placebo but with comparable weight and lipid profiles
The investigational agent bifeprunox maintains stabilized
schizophrenia significantly longer than placebo but with comparable weight and
lipid profiles, according to 6-month trial data presented at the annual meeting
of the American Psychiatric Association.
"Schizophrenia is a chronic, lifelong illness, and
long-term management of the illness presents many challenges," commented
Daniel Casey, MD, Professor, Psychiatry and Neurology, Oregon Health and Science
University. "Clinicians need new treatment options to help patients manage
schizophrenia over the long term."
Analysis of data from the 6-month, phase III trial showed
that bifeprunox significantly prolonged time to symptomatic deterioration and
that patients treated with bifeprunox experienced decreases in body weight and
body mass index compared with placebo.
In addition, bifeprunox showed favorable effects on total cholesterol, triglycerides,
and very-low-density lipoprotein and low-density-lipoprotein cholesterol comparable
with those found for placebo over the course of the study.
In these analyses, the most common side effects reported with bifeprunox (incidence
of greater than or equal to 5 percent and twice the placebo rate) included nausea,
vomiting, dizziness, anorexia, akathisia, dyskinesia and asthenia.
"We are encouraged by these additional analyses of clinical data, which
underscore bifeprunox's favorable weight and lipid profile," said Earl Sands,
MD, Vice President, Research and Development at Solvay Pharmaceuticals, Inc. "Bifeprunox,
if approved, may be an important treatment option in the long- term management
of adult patients with schizophrenia."
|