Healthesystems has previously reported on tanezumab, an investigational, non-opioid biologic that selectively targets and inhibits nerve growth factor, an important mediator of pain. The drug received FDA Fast Track designation in 2017, expediting certain review procedures, due to the drug’s potential to offer significant pain relief without the risks of opioids.
In the last few months, Phase 3 clinical trials have yielded positive results for the use of tanezumab in chronic low-back pain and osteoarthritis, indicating that a new type of pain medication could soon be on the market.
Study A4091509, a randomized, double-blind, placebo and active controlled Phase 3 clinical trial, involved 1,800 patients suffering from chronic low-back pain for an average of 10 years with a documented history of inadequate treatment responses to other medications.
Trial results found that subcutaneous tanezumab injections, delivered seven times at eight-week intervals for 56 weeks, yielded a significant impact of pain on patients’ ability to function in everyday life, with tanezumab offering superior pain relief compared to placebo.
Meanwhile, Study A4091057, a randomized, double-blind, placebo-controlled trial of 810 patients experiencing osteoarthritis of the hip or knee, found that subcutaneous tanezumab injections, delivered every eight weeks for 24 weeks, resulted in a statistically significant improvement in pain and physical function when compared to placebo.
Both studies found tanezumab to be well-tolerated from a safety standpoint, and there are currently trials underway to see if tanezumab can help with pain resulting from bone cancer. If those trials also see positive results, it is possible that tanezumab could potentially see an even more diverse list of possible indications in the future, offering patients and providers more options in the treatment of pain.
