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Chronic pain studies in clinical trial-program halted for certain patients
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Pfizer, Inc., announced Monday evening it was halting several studies in the clinical trial program for the investigational compound tanezumab at the request of the U.S. FDA.
Chronic low back pain and painful diabetic peripheral neuropathy studies were ceased, though Pfizer noted in a press release that investigation of the compound continues in some areas of high unmet medical need – including cancer pain.
Tanezumab is a recombinant humanized monoclonal antibody developed by Pfizer to target nerve growth factors and assist in the treatment of pain.
The FDA’s request follows further consideration of reports of adverse events in patients with osteoarthritis taking tanezumab as well as the agency’s concerns regarding the potential for such events in other patient populations in which the compound is being studied, according to the press release.
Pfizer announced the suspension – at the FDA’s request – of tanezumab studies in patients with osteoarthritis on June 23 following reports that tanezumab patients experienced a worsening of osteoarthritis leading to joint replacement. Other clinical programs were allowed to continue at the time.
For studies on clinical hold, recruitment of new patients and the dosing of existing patients are suspended.