Janssen Pharmaceuticals' Nucynta (tapentadol) extended-release (ER) tablets have been found effective in providing pain management among adults with chronic moderate to severe, painful diabetic peripheral neurophysiology (DPN) compared to placebo.
Tapentadol is a centrally-acting synthetic oral analgesic, available by prescription only and indicated for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
The randomised-withdrawal, placebo-controlled Phase 3 study enrolled adult patients who had moderate to severe chronic painful DPN for six months or more and a history of analgesic use for painful DPN for three months or more.
The trial included three phases: an open-label phase, during which the optimised 100mg-250mg two times a day dose of tapentadol ER was determined for each patient; a 12-week double-blind maintenance phase, during which patients with a one-point or greater reduction in pain intensity were randomised either to continue taking tapentadol ER or to receive placebo; and a follow-up period after discontinuation of drug.
The study's primary efficacy endpoint was the mean change in average pain intensity from baseline to the last week of the 12-week, double-blind maintenance phase, as determined by an 11-point pain rating scale or numerical rating scale (NRS).
During the double-blind treatment phase, efficacy was maintained in the tapentadol ER group, as indicated by the mean change in pain intensity of 0.28, while pain increased in the placebo group.
The study also reported that patients undergoing three weeks of treatment with tapentadol ER and those who continued on an optimised dose of tapentadol ER for an additional 12 weeks experienced better pain control compared to those who switched to placebo.
Christine Auschwitz, Janssen Research & Development Integrated Operations vice president and head, said the Phase 3 data demonstrated that tapentadol ER was effective at providing pain management for patients with chronic, moderate to severe pain associated with DPN.
"Janssen has a long history of helping physicians provide responsible treatment for patients to relieve their acute and chronic pain. We are committed to developing new pain management options for the millions of Americans who have painful DPN," Auschwitz added.
Image: The Phase 3 study demonstrated the efficacy of tapentadol extended-release tablets in managing pain. Photo courtesy of: Vberger.