FDA lifts ban on Pfizer Lilly pain study
pharmafile | March 24, 2015 | News story | Research and Development, Sales and Marketing | Cancer, FDA, Pfizer, lilly, pain, tanezumab
Pfizer and Eli Lilly will resume Phase III clinical trials of tanezumab following the FDA lifting a ban on trials of this class in pain medicines.
As a result, Pfizer will receive a $200 million payment from Lilly under the terms of a collaboration agreement between the two companies to jointly develop and sell the drug.
The companies had been conducting late-stage trials of tanezumab in 11,000 patients with chronic pain. But in 2012 the US regulator placed a hold on these studies after nervous system side effects emerged during studies of similar drugs – monoclonal antibodies that block a protein called nerve growth factor (NGF) – conducted by other companies. Trials of tanezumab and other NGF receptor blockers for terminal cancer pain were allowed to continue.
The FDA has now lifted the hold on studies of tanezumab for chronic pain “after a review of a robust body of non-clinical data characterising the sympathetic nervous system response to tanezumab”, the regulator says.
In 2010 Pfizer had suspended late-stage trials of tanezumab, despite showing initially promising results as a treatment for knee and lower back pain in people with osteoarthritis after reports that patients’ osteoarthritis had worsened – although the FDA later recommended that the osteoarthritis trials could continue if patients taking other non-steroidal anti-inflammatory drugs were excluded.
“We are pleased with the FDA’s decision as chronic pain remains an area of significant unmet medical need and we believe tanezumab has potential to offer a new, non-narcotic option,” says Steve Romano, senior vice president and head of global medicines development at Pfizer’s global innovative pharmaceuticals business.
And David Ricks, Lilly senior vice president and president of Lilly bio-medicines adds: “We’re confident that tanezumab, if approved, can be an innovative treatment with the potential to help millions suffering from painful conditions.”
It is estimated that nearly one in five adults suffer from chronic pain. Should tanezumab be approved, it could reach sales of $100 million in 2020, according to financial services company Cowen and Co. This could rise if the drug is approved for other pain conditions including terminal cancer pain and diabetic neuropathy.
Lilian Anekwe
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