Weeks after it had stopped testing its drug tanezumab in arthritis patients, the pharmaceutical company Pfizer have suspended studies of the same drug for back pain due to concerns over side effects in some patients. The US Food and Drug Administration (FDA) requested the halting of the late-stage study of the drug, which Pfizer was developing to treat chronic lower back pain and nerve damage caused by diabetes .
The FDA request was because of reports of side effects in patients with osteoarthritis that were taking tanezumab, and due to worries about similar problems in other patients taking the drug. Pfizer have said they will continue to work with the FDA to determine the scope of continued clinical trials of tanezumab, although it will carry on testing the drug in some areas, such as for cancer pain.
When tests were initially halted, there were suggestions that the relief brought by the drug, which Pfizer had hailed as a major breakthrough against back pain, was so effective that patients were overusing their joints, which was causing them to need joint replacements earlier than otherwise would be the case.
The programme by New York-based Pfizer, who spend about USD9 billion a year developing new drugs, consisted of nearly 20 patient studies, including several for osteoarthritis, a common condition brought about by wear and tear on the joints, making it a potentially huge market.
Pfizer have admitted that one late-stage study of tanezumab for treating osteoarthritis patients has been completed, and that two other late-stage osteoarthritis studies have finished treating patients, with their data now being analysed.
Another diabetes drug under suspicion
Thu, 22 Jul 2010
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