FDA Fast Track Designation Granted for Pfizer and Eli Lilly’s Innovative Pain Treatment

Tanezumab is currently in global Phase III trials for chronic pain.

Pfizer Inc and Eli Lilly and Company have announced that the FDA has granted its Fast Track designation to tanezuma, an investigational humanized monoclonal antibody. Tanezumab is being used for the treatment of chronic pain in patients with osteoarthritis (OA), as well as chronic low back pain (CLBP). The treatment works by selectively targeting, binding to and inhibiting nerve growth factor (NGF).

NGF is a major cause of pain in patients suffering from these conditions. NGF levels increase when there is trauma, injury, inflammation and chronic pain — the inhibition of NGF may help do away with such pain. By keeping these levels at bay, tanezuma could potentially keep the pain produced by muscles, skin and organs from ever reaching the spinal cord or brain, effectively stopping pain in its tracks. The drug has a completely different mechanism than opioids or analgesics, as well as nonsteroidal anti-inflammatory drugs (NSAIDs).

Ken Verburg, Chief Development Officer of Neuroscience & Pain for Pfizer Global Product Development commented on the exciting potential of the breakthrough therapy. “If approved, tanezumab would be the first in a new class of non-opioid chronic pain medications,” he said. “We believe it would represent an important medical advance in the treatment of debilitating osteoarthritis and chronic low back pain for patients who do not experience adequate pain relief or cannot tolerate currently available pain medications.”

If effective, millions could benefit from the treatment option. Pain associated with OA, as well as back pain, is widespread globally. Tanezumab is currently in Phase III of global clinical trial development, with six studies taking place on approximately 7,000 patients. These patients are suffering from osteoarthritis and chronic low back pain, as well as from cancer pain. In each instance, patients did not report any relief from prior dosage of already approved therapies and are therefore seeking a feasible treatment. The results from these trials will be available for release in 2018. In trials, tanezumab is administered by a health care professional subcutaneously every eight weeks. The treatment is given anywhere from 16 to 56 weeks, depending on patient need and pain severity. This is followed by an additional 24 weeks to monitor patient reactions for side effects and safety.

Christi Shaw, the Senior Vice President and President for Lilly Bio-Medicines, commented on the commitment of the company to push the therapy forward, creating a much-needed alternative to pain treatment for millions. "It is estimated that there are more than 27 million Americans currently living with osteoarthritis and 23 million living with chronic low back pain, many of whom fail to achieve adequate pain relief despite treatment with various types of pain medications,” she explained. “We are committed to offering innovative solutions to people suffering from chronic pain conditions, and look forward to working closely with the FDA to facilitate the development of tanezumab.”

Pfizer and Eli Lilly and Company have partnered on this innovative collaboration starting in 2013 and entering into a, “worldwide co-development and co-commercialization agreement” to push tanezumab forward.

 

Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College.