Pfizer/Lilly non-opioid pain drug shows more positive results
Results from a new study of Pfizer and Lilly’s non-opioid pain drug tanezumab have shown that it can be effective in osteoarthritis in higher doses, but lower doses remain ineffective and the drug had more adverse safety events than its comparators.
The objective of the study was to compare the long-term joint safety and 16-week efficacy of tanezumab relative to nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with moderate-to-severe osteoarthritis (OA) of the hip or knee.
The tanezumab 5 mg treatment arm met two of the three co-primary efficacy endpoints, demonstrating a statistically significant improvement in pain and physical function compared to NSAIDs at the 16-week analysis, while patients’ overall assessment of their OA was not statistically different than NSAIDs.
Patients who received tanezumab 2.5 mg did not experience a statistically significant improvement in pain, physical function or patients’ overall assessment of their OA at 16 weeks compared to NSAIDs.
This is consistent with other studies of the drug that have shown it to be less effective in smaller doses.
In the safety analysis, there was a higher rate of joint safety events in the tanezumab arms compared to NSAIDs at 80 weeks; the difference was statistically significant.
“We are analysing these findings in the context of the recent Phase 3 results as we assess potential next steps for tanezumab,” said Ken Verburg, tanezumab development team leader, Pfizer Global Product Development. “We plan to review the totality of data from our clinical development program for tanezumab with regulatory authorities.”
In February the companies announced positive results for the drug in chronic lower back pain.
Tanezumab is also being investigated for cancer pain due to bone metastases.
Development of the nerve growth factor (NGF) inhibitor drug and rivals from the same class have been delayed by years because of the FDA’s concerns that they could accelerate joint destruction.
But the FDA allowed trials to restart in light of the opioid addiction crisis that has been linked with hundreds of thousands of deaths across America and has prompted action from the government – NGF inhibitors do not have the same addictive potential as opioid drugs such as fentanyl.
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