Data comparing NUCYNTA to oxycodone IR for osteoarthritis pain presented at 29th APS

May 7 2010

A post-hoc analysis of a Phase 3 safety study demonstrated that NUCYNTA® (tapentadol) tablets were associated with a lower incidence of nausea, vomiting and constipation when compared to oxycodone immediate release (IR) tablets in elderly patients with moderate to severe low-back or osteoarthritis pain.  These data will be presented during a poster session today at the 29th Annual Scientific Meeting of the American Pain Society (APS), and are supported by PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., and its research affiliates, Ortho-McNeil-Janssen Scientific Affairs, L.L.C. (OMJSA) and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), as well as Grunenthal GmbH.

This post-hoc analysis of the original Phase 3 study evaluated the safety profile of tapentadol IR>

The analysis demonstrated that tapentadol IR was associated with lower incidences of specific gastrointestinal side effects versus oxycodone IR (46.8% vs. 68.9%, respectively) as well as lower incidences of study discontinuation due to gastrointestinal side effects versus oxycodone IR (15.8% vs. 24.4%, respectively). No significant between-age group differences in efficacy were observed for patients in the tapentadol IR group (P = 0.521 for patients less than 65 vs. patients greater than or equal to 65 years of age) or the oxycodone IR group (P = 0.987 for patients less than 65 vs. patients greater than or equal to 65 years of age).

Information regarding the original double-blind, randomized, active-control, flexible-dose, 90-day, Phase 3 study in patients greater than or equal to 18 years of age with moderate to severe low back pain or osteoarthritis pain was presented at the American Pain Society Annual Meeting in May 2008.  (Press release available online at: http://www.jnj.com/connect/news/all/20080509_160001.  Publication: Hale et al. Curr Med Res Opin.  2009; 25:1095-1104).

"Low back and osteoarthritis pain are common among patients 60 years and older," said Gary Vorsanger, M.D., Ortho-McNeil Janssen Scientific Affairs, L.L.C. "These data help illustrate that NUCYNTA® may be an important treatment option to consider for older patients with moderate to severe acute low back or osteoarthritis pain."

In the post-hoc analysis, the most common adverse events (greater than or equal to 10%) among elderly patients in either treatment group were nausea, constipation, vomiting, dizziness, somnolence, and pruritus (itching). Incidences of constipation (19.0% vs. 35.6%, respectively) and the composite of nausea and/or vomiting (30.4% vs. 51.1%, respectively) were statistically significantly lower with tapentadol IR (nominal P less than 0.05 for both comparisons) among elderly patients receiving tapentadol IR versus oxycodone IR.