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Pfizer suspends more pain drug studies

Following a request from the US Food and Drug Administration, Pfizer has suspended certain trials of its pain drug tanezumab

Following a request from the US Food and Drug Administration (FDA), Pfizer has suspended trials of its drug tanezumab in patients with chronic low back pain and diabetic peripheral neuropathy.

The news comes a month after Pfizer halted its worldwide phase III clinical studies of the drug in osteoarthritis patients based on a request from the FDA. This was due to a small number of reports of osteoarthritis worsening, in some cases even leading to the need for joint replacement.

At the time, it wasn't clear whether the FDA would ask for other studies to be halted due to the possibility that the drug could be harmful in patients who did not already have osteoarthritis. However, the federal agency has now raised "concerns regarding the potential for such events in other patient populations in which the compound is being studied," the company said.

The clinical hold, which is effective immediately, suspends the recruitment of new patients as well as the dosing of existing subjects.

Clinical studies will continue for certain indications in which the seriousness of the condition and the unmet medical need might justify the drug's potential risks, Pfizer noted. For example, cancer pain studies of tanezumab are ongoing.

"Pfizer will continue to work with the FDA to reach a common understanding about the appropriate scope of continued clinical investigation of tanezumab," the company said.

Tanezumab is a humanised monoclonal antibody directed against nerve growth factor. It was acquired by Pfizer when the company bought the biotech firm Rinat in 2006.

20th July 2010

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