Pfizer and Lilly's Non-Opioid Painkiller Shows Mixed Results in Phase III
Pfizer and Eli Lilly and Company announced top-line results from a Phase III clinical trial of two doses of tanezumab in moderate-to-severe osteoarthritis (OA) of the hip or knee. The results were mixed, with the 5 mg dose meeting two of the three co-primary efficacy endpoints but missing on the patients’ overall assessment of their OA. In the 2.5 mg cohort, patients didn’t describe a statistically significant improvement in pain, physical function or overall assessment. The tanezumab arms also had more safety events compared to patients receiving nonsteroidal anti-inflammatory drugs (NSAIDs). There were also 10 deaths in the study, nine being in the tanezumab cohort. None of these were believed to be treatment-related. Tanezumab is a new category of pain drugs that target nerve growth factor. It has been projected as a possible blockbuster, particularly in light of the pushback against opioids due to abuse. The lower dose does not appear to be useful, although the higher dose, despite not meeting patient assessments, showed a statistically significant improvement in pain and physical function compared to NSAIDs at the 16-week mark.