Pfizer Inc. announced, at the request of the U.S. Food and Drug Administration (FDA), the suspension of the chronic low back pain and painful diabetic peripheral neuropathy studies in the clinical program for the investigational compound tanezumab. Investigation of the compound continues in some areas of high unmet medical need, including cancer pain.
The FDA’s request follows further consideration of reports of adverse events in osteoarthritis patients taking tanezumab, and the agency’s concerns regarding the potential for such events in other patient populations in which the compound is being studied. Pfizer announced the suspension of tanezumab studies in patients with osteoarthritis in a June 23 press release.
For studies on clinical hold, recruitment of new patients and the dosing of existing patients are suspended.
Pfizer will continue to work with the FDA to reach a common understanding about the appropriate scope of continued clinical investigation of tanezumab.