FDA Grants “Fast Track” To Non-Opioid Medication
The Food and Drug Administration has designated a new non-opioid medication called tanezumab to be put on “fast track.” The drug is indicated for persons with chronic lower back pain and osteoarthritis. It targets and binds to a protein known as nerve growth factor, which multiplies in the body after injury and inflammation. As a result, pain signals are prevented from reaching the brain.
Tanezumab is the first nerve growth inhibitor to be given this designation. According to the FDA, fast trackfast track is “a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.”
Ken Verburg of Pfizer Global Product Development stated that the company believes that tanezumab will be “an important medical advance” in the treatment of the two painful conditions for patients who “do not experience adequate pain relief or cannot tolerate currently available pain medications.”
Pfizer is joining forces with Eli Lilly in development, and the two drug manufacturers are recruiting 7,000 participants for tanezumab studies in which patients will be injected with the drug once every eight weeks for periods that range from 16-56 weeks. Results are not expected until 2018.
An estimated 27 million persons in the U.S. currently suffer from osteoarthritis, and another 23 million suffer from chronic lower back pain.
In 2010, it was the FDA that delayed development of nerve growth inhibitors due to safety reasons, as a small number of patients needed joint replacements when their disease worsened. The research did not continue until 2015, and Pfizer states current studies include joint and sympathetic nervous system safety measures.
Last year, another nerve growth factor drug called Fasiumab was being developed and studied by Teva and Regeneron Pharmaceuticals, but was also stopped by the FDA after one patient revealed signs of serious joint disease. The companies stated they intended to redesign the study to exclude patients with severe osteoarthritis.
~ G. Nathalee Serrels, M.A., Psychology