RARITAN, N.J. — A drug made by Johnson & Johnson may be effective in reducing pain in patients with a complication of diabetes, according to a late-stage clinical study.
The phase-3 study, published in the January issue of the journal Current Medical Research and Opinion, found that extended-release tapentadol was more effective than placebo in relieving moderate to severe chronic pain in patients with diabetic peripheral neuropathy. J&J markets an immediate-release formulation of the drug under the brand name Nucynta, which the Food and Drug Administration approved in November 2008.
“What’s encouraging is that at the beginning of this study, the average pain rating across the entire group of patients was severe, but after three weeks on tapentadol ER, the average pain score dropped substantially to a range considered to be mild pain,” therapeutic leader for pain at J&J subsidiary Ortho-McNeil-Janssen Scientific Affairs Bruce Moskovitz said. “After double-blind randomization, the group of patients that stayed on tapentadol ER maintained its pain reduction, while the group that switched to placebo experienced a significant increase in its average pain score.”