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BMJ 2010; 341 doi: (Published 05 October 2010) Cite this as: BMJ 2010;341:c5482

Safety worries halt trials of promising biological analgesic

Tanezumab is a monoclonal antibody directed against nerve growth factor, one of the mediators of pain in damaged or inflamed tissue. This new agent has analgesic potential, and an early trial reports good results for people with severe osteoarthritis of the knee. Two infusions of tanezumab at a variety of doses significantly improved objective measures of pain over 16 weeks, relative to a placebo control (improvement of 45-62% v 22% for controls; P<0.001). Patients given the active drug also reported significantly better global response. Both groups had access to rescue pain relief with paracetamol and tramadol. The trial was paid for by a Pfizer subsidiary.

So it is effective, but is it safe? The US Food and Drug Administration (FDA) is already worried about this new biological analgesic and has suspended three further trials while researchers investigate the role of tanezumab in 16 cases of joint failure that emerged earlier this year. All patients needed joint replacement for progressive osteoarthritis with bone necrosis. One commentator (doi:10.1056/nejme1004416) suspects …

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