Nucynta (J&J Janssen) provides pain management for Patients with Diabetic Peripheral Neuropathy

A Phase III study suggests Nucynta ER (tapentadol) tablets, from J&J Janssen, were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful Diabetic Peripheral Neuropathy (DPN). This trial had three phases: an open-label phase, in which the individually optimized tapentadol ER dose (100-250 mg two times per day) 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 from beginning to end of titration were randomized either to continue taking tapentadol ER (at their optimal dose) or to receive placebo; and a follow-up period. Among patients who had at least a one-point reduction in pain intensity during three weeks of treatment with tapentadol ER, the study showed those who continued on an optimized dose (100-250 mg twice daily) for an additional 12 weeks experienced significantly better pain control compared to those who switched to placebo. Treatment-emergent adverse events reported in 10 percent or more of tapentadol ER-treated patients during the double-blind maintenance period included nausea (21.1 percent) and vomiting (12.7 percent). Lead author was Aaron I. Vinik, Director of Research and Neuroendocrine Unit at Strelitz Diabetes Center for Endocrine and Metabolic Disorders at Eastern Virginia Medical School. The findings of this study are consistent with those of another study published last year, which found tapentadol ER to be effective versus placebo.