CHICAGO, Sept. 30 (UPI) — The development of a promising drug for osteoarthritis pain was put on hold when some patients in drug trials developed worse symptoms, health officials said.
A phase II clinical trial of the first new type of drug for musculoskeletal pain since aspirin shows that it significantly reduces knee pain in osteoarthritis, the most common osteoarthritis pain, a Northwestern University release said Thursday. But phase III trials of the drug tanezumab were put on hold after 16 of several thousand participants developed progressively worsening arthritis and bone changes that required total joint replacements.
“The bottom line is this is a very effective drug for relieving pain; unfortunately, it appears some people go on to have their osteoarthritis progress more quickly,” Dr. Thomas Schnitzer, a rheumatologist and professor in the department of physical medicine and rehabilitation at Northwestern Medicine, said. “The long-term safety of tanezumab needs to be better understood.
“The effects of tanezumab were remarkable,” principle investigator Dr. Nancy Lane, a professor of internal medicine at the University of California, Davis, said. “People on the drug went from having very limited activity to practically being on the dance floor. No medication available today has such dramatic results.”
Schnitzer and Lane said the worsening of certain patients’ conditions could be because the drug allowed patients to increase physical their activity to the point of putting more stress on their diseased joints.
Schnitzer said the Food and Drug Administration is examining data to decide how to proceed.
“The FDA may decide it’s too dangerous overall or, rather, that there may be a specific patient population in which it should not be used or who need to be warned about possible serious side effects,” he said.
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