The current study was done in 191 sites in eight countries in North America, Europe and Asia. It involved patients who did not get pain relief after trying at least three different pain drugs, including opioids.
Patients underwent treatment for a little over a year. At four months, patients taking 10 milligrams of tanezumab reported significantly more pain relief than those using the placebo.
Also, after four months, more patients taking the experimental drug reported pain relief than those taking tramadol.
Markman said the drug “is very promising and really represents a step forward.”
Lower back pain affects 80% of Americans, and in as many as 20% of cases can become chronic and debilitating and disruptive, said Dr. Yili Huang, director of pain management at Northwell Health Phelps Hospital in Sleepy Hollow, N.Y.
“Any potentially effective new treatment is truly exciting,” said Huang, who was not involved in the study.
Many of the currently available treatments for chronic lower back pain act on the same anti-inflammatory or opioid receptors, he said. “Treating a new target along the pain pathway can open the door to potentially safer and more effective treatments,” Huang noted.
Medical treatment of lower back pain is becoming increasingly challenging as many medications may have dangerous long-term side effects that can lead to cardiovascular disease, addiction, and kidney and liver disease, Huang said.
“The efficacy of tanezumab in treating pain in patients who have already failed treatment with these medications, including opioids, is very encouraging, but we must not discount the very small chance of it causing potentially devastating serious joint problems,” he said.
“Like all treatments, we must weigh the risks and benefits before proceeding, but it is a welcome addition to the treatment toolbox,” Huang added.
Because the drug doesn’t yet have FDA approval, Markman said it’s too early to estimate the cost. But like most new drugs, he said it will likely be expensive.
The report was published online June 19 in the journal Pain.