A Painstaking Approach: Can Anti-NGFs Give Relief To Pharma Pipeline Woes?
Analgesic drugs have reached a painful point. Unwanted side effects and abuse potential have made existing drug categories such as non-steroidal anti-inflammatories and opioids unappealing prescriptions for patients in chronic pain. But a new class of antibodies that inhibit the crucial protein nerve growth factor could spell relief for millions of chronic pain sufferers - if they can demonstrate safety and efficacy
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Pfizer and Lilly plan to resume Phase III testing of their nerve growth factor inhibitor after FDA lifted a partial hold on tanezumab. But J&J is also poised to run new Phase III studies with fulranumab.
Nothing has arguably hurt pharmaceutical investors and dealmakers quite so often and with such force as novel pain drug development failures. As a result, a once hot field has gone cold. Despite setbacks, great strides have been made in understanding the complex biology of pain. Scientists have discovered numerous new pain pathway targets with the potential for designing effective agents with fewer off-target effects. Improvements that make preclinical studies more predictive of clinical success are also opening up new opportunities. At the same time, drug developers now understand better how to design drug trials that can segment patient populations to demonstrate therapeutic efficacy more precisely, potentially reducing placebo effects and paving the way for an era of personalized pain medicine.
Safety concerns require Pfizer to scupper two additional studies of its Phase III tanezumab, casting doubt on an entire class of new pain drugs.