Tanezumab Demonstrated Analgesic Efficacy Across Three Pain Conditions in Phase Two Studies
SAN ANTONIO, Feb. 4 /PRNewswire-USNewswire/ -- Tanezumab, a humanized monoclonal antibody that targets nerve-growth factor, reduced pain in three common pain conditions, according to the results from three phase two studies presented today in a single poster at the American Academy of Pain Medicine's 26th Annual Meeting.
Researchers from Pfizer presented the results from three separate randomized, double-blind, placebo-controlled, clinical trials of tanezumab involving a total of 725 patients. One trial was conducted in each of the following chronic pain conditions: osteoarthritis (OA), chronic low back pain (CLBP), and interstitial cystitis (IC) -- chronic inflammation of the urinary bladder wall. At the beginning of each study, patients recorded their pain severity in a daily pain diary using numeric scales specific to their condition. For instance, in the osteoarthritis participants, "walking pain" was measured.
In the CLBP study, patients were randomized to receive a single intravenous infusion of tanezumab (200ug/kg) or placebo. A third treatment group received naproxen twice daily. In the IC study patients were randomized to receive tanezumab (200ug/kg) or placebo. The OA study was a multiple dose study and patients were randomized to receive one intravenous infusion of tanezumab (10, 25, 50,100 or 200ug/kg), or placebo twice during the study separated by an eight week interval.
Participant diaries were evaluated by the investigators after six weeks in the IC and CLBP studies and 16 weeks in the OA study. In each clinical trial, patients treated with tanezumab reported significantly greater reductions in their pain when compared to patients treated with placebo. Pain reduction was also greater for CLBP patients taking tanezumab compared to naproxen (p=0.04).
"These results are encouraging," said Leslie Tive, Ph.D., Pfizer senior director of Medical Affairs. "Tanezumab could be a promising new therapeutic tool for physicians to treat some common chronic pain conditions."
The most commonly reported adverse events across these studies were abnormal peripheral sensation, muscle ache, and pain in the extremities. Adverse events of abnormal peripheral sensation (tingling, numbness, burning sensations or increased sensitivity to touch) were generally transient, mild, and not associated with clinically meaningful neurological deficits.
Tanezumab is an investigational humanized monoclonal antibody currently in phase three clinical trials for the treatment of osteoarthritis.
Tanezumab targets nerve growth factor (NGF). A primary role of NGF is to mediate and orchestrate the pain response to injury.
For more than 25 years, the American Academy of Pain Medicine (AAPM) has been the medical specialty society representing more than 2,200 physicians practicing in the field of comprehensive pain medicine. The Academy is involved in education, training, advocacy and research in the specialty of pain medicine.
Posted: February 2010