RARITAN, N.J. An investigational drug made by Johnson & Johnson for treating pain showed significant reduction in pain intensity compared with placebo in patients with moderate to severe lower back pain, according to results of a late-stage clinical trial announced Monday.
Results of a phase-3 trial, published online in the journal Expert Opinion on Pharmacotherapy, indicated that tepentadol extended-release tablets reduced pain by at least 30% in patients compared with placebo. The drug uses the same active ingredient as J&J’s Nucynta, an immediate-release formulation.
“The study provides important data regarding the safety and efficacy of tapentadol ER,” said Bruce Moskovitz, therapeutic area leader for pain at Ortho-McNeil-Janssen Scientific Affairs, a division of J&J. “We are pleased that results show tapentadol ER may effectively relieve moderate to severe chronic low back pain while demonstrating a favorable tolerability profile.”