The data are expected to be presented during a poster session at the 29th Annual Scientific Meeting of the American Pain Society (APS), and are supported by PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals and its research affiliates, Ortho-McNeil-Janssen Scientific Affairs, (OMJ) and Johnson & Johnson Pharmaceutical Research & Development, (J&JPRD), as well as Grunenthal GmbH.
The post-hoc analysis of the original Phase 3 study evaluated the safety profile of tapentadol IR (50 or 100mg dosed every four to six hours as needed) over a 90-day period among elderly patients. The study also evaluated an oxycodone IR active comparator group (10 or 15mg 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. No between-age group differences in efficacy were observed for patients in the tapentadol IR group or the oxycodone IR group.
Additionally, information regarding the original double-blind, randomised, active-control, flexible-dose, 90-day, Phase 3 study in patients 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.
Gary Vorsanger, MD of Ortho-McNeil Janssen Scientific Affairs, said: “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.”