Janssen Pharmaceuticals reported Phase III results demonstrating the efficacy of Nucynta® ER (extended release tapentadol) in managing pain associated with chronic diabetic peripheral neuropathy (DPN). Janssen says the data is consistent with that of a separate study reported in 2011 in patients with DPN.
Nucynta ER is a centrally acting analgesic that acts as both a mu-opioid receptor agonist and norepinephrine reuptake inhibitor. The drug is classified as a Schedule II controlled substance, and is indicated for managing moderate-to-severe chronic pain in adults requiring continuous, 24-hour opioid analgesia for extended periods.
The latest Phase III study, in patients with moderate-to-severe chronic painful DPN, included two treatment phases. The initial open-label stage involved a three-week titration period during which the tapentadol ER dose was optimized for each patient. During the second, double-blind maintenance phase, 318 patients who had demonstrated pain intensity reduction of at least one point during the open-label phase were randomized either to continue taking their optimized dose of tapentadol ER, or placebo for 12 weeks. The results showed that while patients switched to placebo demonstrated an average increase in pain intensity of 1.3 points, pain reduction was maintained in patients remaining on tapentadol ER.
Tapentadol was originally discovered by Grünenthal, which markets immediate and extended formulations of the drug, trademarked Palexia® in various markets in Europe. Janssen has an exclusive license to the drug in the U.S., Canada, and Japan, and another 80 or so markets in Asia Pacific, Latin America, Africa, and some European countries.