Schizophrenia Daily News Blog

Bifeprunox: New Schizophrenia Medication Phase III Study Results

In May of 2007, pharmaceutical companies Wyeth, Solvay and psychiatric research company Lundbeck reported more recent findings on bifeprunox, a possible new drug for treating schizophrenia that has been in the works for some time now. New research including 6-months of data looked at stabilized adults with schizophrenia using a randomized, double-blind, placebo-controlled phase III study. (basic drug study information). Of course, with all new medications - many side effects don't become well known until many years after launch, so its impossible to say for sure what additional side effects may be caused by a new medication.

Bifepronox news has been covered on this site before, and was seen as a possible new advancement in the medication treatments of schizophrenia. In 2006, phase III trails were delayed and not expected till 2008; but in a positive turn, the first 6-months of data are available now. In 2004, Schizophrenia Bulletin had these hopeful things to say about bifeprunox:

Bifeprunox, is a novel third-generation antipsychotic that exhibits partial agonist properties for dopamine D2 as well as serotonin 5-HT1A receptors. Bifeprunox, which was developed by Solvay, has shown efficacy superior to haloperidol in Phase III clinical trials, with few side effects. The drug is effective on both positive and negative symptoms and appears to present little risk for weight-gain, cardiovascular, or extrapyramidal side effects.

In analyses of data from one Phase 3, six-month, randomized, double-blind, placebo-controlled study:

• Compared with placebo, bifeprunox significantly prolonged time to deterioration over six months.
• Bifeprunox patients experienced decreases in body weight and body mass index vs. placebo over six months.
• Bifeprunox patients showed favorable effects on total cholesterol, triglycerides, very low-density lipoprotein and low-density lipoprotein, comparable with placebo over a six-month period.
• 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," says Earl Sands, M.D., 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."