J&JPRD, Grunenthal Release Phase 3 Open-label Study Results

Tapentadol is a centrally acting oral analgesic that binds to mu-opioid receptors and inhibits norepinephrine reuptake. Although the exact mechanism of action is not known, these two mechanisms, which affect established pain pathways, are thought to be responsible for pain relief with tapentadol. The tapentadol molecule is classified as Schedule II of the Controlled Substances Act.

The study also demonstrated that Tapentadol ER provided sustainable relief of moderate to severe chronic knee or hip osteoarthritis pain or chronic low back pain for up to one year. At baseline, mean pain intensity scores in the Tapentadol ER and Oxycodone CR groups, respectively, were 7.6 and 7.6; at endpoint, they had decreased to 4.4 and 4.5.

The primary objective of this comparitive study was to evaluate the safety of twice-daily doses of Tapentadol ER (100 to 250mg) over one year.

Bruce Moskovitz, therapeutic area leader for pain at Ortho-McNeil Janssen Scientific Affairs, said: “We are encouraged by these study results as they illustrate the tolerability of Tapentadol ER compared with Oxycodone CR, a standard chronic pain treatment. We are pleased about the possibility of bringing this investigational compound forward to patients in the future.”

J&JPRD has included the study as part of its new drug application (NDA) to the FDA for Tapentadol ER tablets for the management of moderate to severe chronic pain in patients 18 years of age or older. The FDA currently is reviewing this application and, if approved, PriCara, division of Ortho-McNeil-Janssen Pharmaceuticals, is expected to market Tapentadol ER in the US.