Tanezumab Non-Opioid Treatment Receives FDA Fast Track Designation for Arthritis
by Dr. C.H. Weaver M.D. updated 1/2019
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for tanezumab for the treatment of chronic pain in patients with osteoarthritis (OA) and chronic low back pain (CLBP). If approved, tanezumab would be the first in a new class of non-opioid chronic pain medications and an important medical advance in the treatment of debilitating pain for patients who do not experience adequate pain relief or cannot tolerate currently available pain medications. Fast Track designation is a process designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs.
Tanezumab is a humanized monoclonal antibody that selectively targets, binds to and inhibits nerve growth factor (NGF). NGF levels increase in the body as a result of injury, inflammation or in chronic pain states. By inhibiting NGF, tanezumab may help to keep pain signals produced by muscles, skin and organs from reaching the spinal cord and brain. Tanezumab works in a different manner than opioids and other analgesics, including nonsteroidal anti-inflammatory drugs (NSAIDs), and in studies to date tanezumab has not demonstrated a risk of addiction, misuse or dependence.
In a recently reported clinical trial 698 patients with OA were treated with placebo (no treatment), two doses of tanezumab 2.5mg, or tanezumab 2.5mg followed by a dose of tanezumab 5mg eight weeks later and directly compared. Tanezumab was generally well tolerated, with approximately 1% of patients discontinuing treatment due to side effects.
Individuals who were treated with two doses of tanezumab separated by eight weeks experienced a statistically significant improvement in pain, physical function and an overall improvement in their OA compared to those receiving placebo.
According to a press release from the developers of tanezumab "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.” The recent opioid epidemic has clearly highlighted the need for new no addictive pain medications to bring relief to these patients.
Results were from a second Phase 3 study evaluating tanezumab in patients with moderate-to-severe OA pain of the knee or hip. Overall 849 individuals were treated with either tanezumab 2.5mg, tanezumab 5mg, or placebo once every 8 weeks over a 24-week treatment period. (3)
Results showed that at 24 weeks, a statistically significant improvement in pain and physical function in patients treated with either tanezumab dose compared with placebo. Tanezumab was found to be well-tolerated and no new safety concerns identified.
These findings add to the growing body of evidence supporting tanezumab as a potential innovative treatment option for individuals with osteoarthritis and other forms of chronic pain.