Tanezumab, an investigational subcutaneously-administered, non-opioid treatment, may benefit patients with moderate to severe chronic low back pain (CLBP), according to top-line results from a Phase 3 study.
Study A4091059, a double-blind, placebo- and active-controlled study, included patients with moderate to severe CLBP who had persistent low back pain for more than 3 consecutive months. Patients (N=1832) were randomized to 1 of 4 treatment groups: placebo every 8 weeks to week 16, then at week 16, patients who met the efficacy responder criteria were switched equally to tanezumab 5mg or 10mg every 8 weeks to week 56; tanezumab 5mg every 8 weeks to week 56; tanezumab 10mg every 8 weeks to week 56; or oral tramadol prolonged-release (PR) daily to week 56.
The primary efficacy measure was change in daily average Low Back Pain Intensity (LBPI) score from baseline to week 16; secondary endpoints evaluated tanezumab through 16 and 56 weeks, including comparisons to tramadol PR; a 24-week safety follow-up period was also included in the study bringing it to 80 weeks of observation.
Results showed that at week 16, tanezumab 10mg was associated with a statistically significant improvement in pain compared with placebo; the 5mg dose, while demonstrating a numerical improvement in pain, did not reach statistical significance when compared with placebo. During the 56-week treatment period, tanezumab was found to be generally well-tolerated. Full findings from the study will be available in a future scientific publication and presentation.
“This is one of the longest studies conducted to date in chronic low back pain,” said Ken Verburg, tanezumab development team leader, Pfizer Global Product Development. “We look forward to further analyzing these results, and believe the data from this study will support our planned future global regulatory submissions in chronic low back pain.”
Tanezumab is a humanized monoclonal antibody that selectively targets, binds to, and inhibits nerve growth factor (NGF). In addition to CLBP, it is being investigated for the treatment of osteoarthritis pain and cancer pain (due to bone metastases).