An extended-release formulation of the drug reduced the level of pain in patients with chronic DPN by half.
Nucynta may offer an effective therapy for a condition difficult to treat with conventional painkillers.
Originally developed by Grünenthal, tapentadol is a new type of centrally-acting analgesic with opioid characteristics.
The extended-release Nucynta gained FDA approval for treatment of chronic pain in August 2011.
The new phase III trial tested Nucynta against placebo in adult patients who had suffered painful DPN for six months or more and in whom conventional painkillers had failed.
After 12 weeks, patients treated with Nucynta reported a drop in pain intensity from an average of 7.3 to 3.6 on a 10-point scale.
The study’s lead investigator, Aaron Vinik of Eastern Virginia Medical School, commented: “Painful DPN is a common and burdensome complication of diabetes, and controlling pain in people with DPN can be challenging. These data suggest tapentadol ER provides a significant reduction in chronic pain in adult patients with DPN.”
The difficulty of treating DPN often leads doctors to prescribe antidepressants as well as painkillers, so Nucynta may represent a breakthrough in this therapy area.