Chronic low back pain and painful diabetic peripheral neuropathy studies have been canned.
Pfizer has nixed two more clinical studies of tanezumab two months after halting a Phase III trial in osteoarthritis patients to treat chronic pain. FDA has now asked that the Phase II stage chronic low back pain and painful diabetic peripheral neuropathy programs also be suspended. Investigation of the compound continues in some areas including cancer pain, according to Pfizer.
FDA’s request follows further consideration of adverse events reports in osteoarthritis patients taking tanezumab. The agency is concerned that there is potential for such events in other patient populations in which the compound is being studied.
On June 23, Pfizer reported the suspension of tanezumab in patients with osteoarthritis. The firm axed the late-stage study in this indication for chronic pain and also stopped tanezumab treatment in osteoarthritis patients enrolled in Phase II trials in other chronic pain settings.
Pfizer said that there were a few reports that osteoarthritis patients receiving the mAb candidate experienced worsening of their disease and needed joint replacements. At the time the company reported that adverse effects had not been recorded in nonosteoarthritis patients taking tanezumab.