Data Comparing NUCYNTA® (Tapentadol) Tablets to Oxycodone Immediate Release Tablets Presented At 2010 American Pain Society Annual Meeting
Baltimore, Md. – 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 Grünenthal GmbH.
This post-hoc analysis of the original Phase 3 study evaluated the safety profile of tapentadol IR (n=158, either 50 or 100 mg dosed every four to six hours as needed) over a 90-day period among elderly patients (?65 years of age). The study also evaluated an oxycodone IR active comparator group (n=45, either 10 or 15 mg dosed every four to six hours as needed).
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