Pfizer Inc has announced that, following a review of the development and commercial portfolios in the Primary Care Business Unit, it is terminating Phase 3 development programs for the investigational compounds esreboxetine for fibromyalgia and PD 332,334 for generalized anxiety disorder (GAD). The decision to terminate these programs will enable the Business Unit to allocate additional resources to higher-potential development programs as part of its continuing effort to deliver greater value to patients and Pfizer shareholders.
After reviewing the results of the first Phase 3 study for PD 332,334 for the treatment of GAD and the existing data for esreboxetine for the treatment of fibromyalgia, along with current market dynamics, it was considered unlikely that either compound would provide meaningful benefit to patients beyond the current standard of care. Neither compound was terminated due to safety reasons.
"While confident in the safety of these compounds, we don't believe that they provide significant benefit over other therapies," said Pedro Lichtinger, President and General Manager, Pfizer's Primary Care Business Unit.
Mr. Lichtinger continued, "In Primary Care, we continually review our portfolio to ensure we are developing medicines in areas of unmet need and have found significant potential opportunities to bring more value to patients and our company. For example, we are advancing the investigational compound tanezumab into areas of pain management beyond osteoarthritis and see potential opportunities for other investigational compounds in other areas of significant patient need, including Alzheimer's disease and thrombosis. Our goal is to use our resources efficiently and effectively to continue to deliver medical innovations to the global health community."
Pfizer will continue to pursue an indication for Lyrica (pregabalin) CV in the treatment of GAD, a chronic disorder characterized by persistent anxiety, exaggerated worry and tension that results in impairment of daily function.
Pfizer is a pioneer in the study of treatments for fibromyalgia, a condition of chronic widespread pain. In June 2007, Lyrica (pregabalin) CV became the first FDA-approved treatment for the management of fibromyalgia, and Pfizer continues to support research and education in this complex pain condition.
Pfizer is notifying all clinical trial investigators involved in studies of both esreboxetine and PD 332,334 to determine the best course of action for their patients. Patients participating in any of these studies should contact their clinical investigational site should they have any questions or concerns.
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