Pfizer and Eli Lilly have announced that the Food and Drug Administration (FDA) has granted the investigational humanized monoclonal antibody, tanezumab, a Fast Track designation as a novel treatment for chronic pain associated with chronic lower back pain (CLBP) and osteoarthritis (OA).
Currently, there is a global Phase 3 program comprised of 6 studies involving approximately 7,000 patients with OA, CLBP or cancer pain with inadequate treatment of pain with approved therapies. Each study is evaluating the efficacy of subcutaneous injection of tanezumab every 8 weeks for treatment periods of 16 to 56 weeks, with a safety follow-up period of 24 weeks.
Tanezumab is a nerve growth factor (NGF) inhibitor and is a first-in-class agent to receive Fast Track approval. As NGF levels are elevated in inflammatory conditions or chronic pain states, tanezumab works by selectively inhibiting NGF, preventing downstream spread of pain signals from the periphery to the spinal cord and brain.
If approved, tanezumab would be the first drug in a new class of non-opioid agents for chronic pain management. Results from the study are expected to be published in 2018.