MADISON, N.J., Dec. 6 /PRNewswire-FirstCall/ -- 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."
The research presented includes investigational data on bifeprunox in adult patients with acute exacerbations of schizophrenia and stable schizophrenia. A synopsis of the abstract objectives and conclusions follows.
Six-Month Maintenance of Stability Study in Stable Schizophrenia * Abstract: Long-Term Efficacy and Safety of Bifeprunox in Patients with Schizophrenia: A Six-Month, Placebo-Controlled Study In this Phase 3 study, researchers investigated the long-term efficacy of bifeprunox in patients with stable schizophrenia by assessing the time to deterioration with bifeprunox, compared with placebo, over a period of up to six months. In addition, the study investigated whether clinical effect, as assessed by the Positive and Negative Syndrome Scales (PANSS), after six weeks of treatment with bifeprunox, is superior to placebo. Bifeprunox was superior to placebo in preventing deterioration over six months in patients with stable schizophrenia. A favorable metabolic profile also was seen for bifeprunox, based on weight changes, lipids and the presence or absence of metabolic syndrome. Metabolic Profile of Bifeprunox * Abstract: The Metabolic Profile of Bifeprunox in the Treatment of Patients with Schizophrenia The purpose of this analysis was to examine the metabolic effects of bifeprunox, compared with placebo or active references, in patients with acute and stable schizophrenia. In the analysis, decreases in body weight and improvement in lipid profiles were observed in patients treated with bifeprunox, with minimal changes in plasma glucose. Weight, triglyceride, total cholesterol and triglyceride: HDL ratios were reduced in patients receiving six months of treatment. Short-Term Studies in Acute Exacerbation of Schizophrenia * Abstract: Efficacy and Safety of Bifeprunox vs. Placebo in the Treatment of Patients with Acute Exacerbations of Schizophrenia In this Phase 3 study, researchers investigated whether bifeprunox treatment is superior to placebo in patients with acute exacerbations of schizophrenia. Researchers also evaluated the safety and tolerability of bifeprunox as compared with placebo. Bifeprunox was superior to placebo in symptoms of schizophrenia, a decrease in body weight, and improvement in the lipid profile. * Abstract: Efficacy and Safety of Bifeprunox in the Treatment of Patients with Acute Exacerbations of Schizophrenia: Results of a Dose-Finding Study In this Phase 3 study, researchers evaluated the efficacy and safety of bifeprunox in the treatment of patients with acutely exacerbated schizophrenia. Bifeprunox showed significant improvement compared with placebo in the treatment of patients with acutely exacerbated schizophrenia. Bifeprunox also was associated with a decrease in weight and improvement in the lipid profile. * Abstract: A Randomized, Double-Blind, Placebo-Controlled Study of Bifeprunox, a Partial Dopamine D2 Receptor Agonist, in Patients with Acute Exacerbations of Schizophrenia In this Phase 2 study, researchers evaluated the efficacy, safety and tolerability of bifeprunox vs. placebo in patients with acute exacerbations of schizophrenia. Although investigators observed no statistically significant improvement in PANSS score for bifeprunox compared with placebo, the metabolic profiles of subjects treated with bifeprunox were favorable and comparable with placebo.
In these studies, the most common side effects reported with bifeprunox (incidence of greater than or equal to 5 percent and twice the placebo rate) were gastrointestinal in nature including nausea, vomiting, constipation and abdominal discomfort.
"We are pleased to report these promising findings that show the potential of bifeprunox to add value to the management and treatment of schizophrenia," says Earl Sands, M.D., Vice President, Research and Development at Solvay Pharmaceuticals, Inc. "We are especially encouraged by the favorable weight and metabolic profile shown in both short- and long-term studies."
In October 2006, Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. announced that a New Drug Application was submitted to the U.S. Food and Drug Administration for bifeprunox, an investigational antipsychotic for the treatment of schizophrenia and for maintenance of stability. Under the terms of a collaboration agreement entered into in March 2004, Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. agreed to co-develop and co-commercialize bifeprunox and two other compounds, which are in earlier stages of development, as treatments for schizophrenia and other psychiatric conditions.
"As the government-sponsored CATIE [Clinical Antipsychotic Trials in Intervention Effectiveness] study showed, a significant need remains for treatment alternatives with improved safety and tolerability profiles to ensure optimal care of individuals with schizophrenia," says Philip Ninan, M.D., Vice President, Neuroscience at Wyeth Pharmaceuticals.
About Schizophrenia
Schizophrenia is a chronic form of psychosis that affects approximately 1.1 percent of the population in the United States in one year. It is characterized by positive and negative symptoms such as hallucinations, delusions, poverty of speech, disorganized thought and emotional blunting. Severity of the symptoms and the long-term pattern of schizophrenia often cause a high degree of disability for patients and place a burden on families, caregivers and communities.
While atypical antipsychotics help reduce positive and negative symptoms, to varying degrees, some may be associated with weight gain, glucose and triglyceride elevations, and altered lipids, which may increase the risk of diabetes and heart disease. These side effects are compounded by the fact that individuals with schizophrenia are more likely than the general population to be overweight or obese, and they have a two-to-four-times higher risk of diabetes than the general population.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
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