Analgesic efficacy of tapentadol immediate release in patients with pain from end stage joint disease

Tapentadol is a novel, centrally acting analgesic in a single molecule with a dual mode of action: mu-opioid receptor agonism and norepinephrine reuptake inhibition. The efficacy of tapentadol immediate release (IR) was studied in a double-blind, randomized, placebo-controlled, multicenter trial of candidates for primary joint replacement surgery for end-stage joint disease. A total of 659 patients, randomly assigned 1:1:1:1, received an oral dose of placebo, tapentadol IR 50 or 75 mg, or oxycodone IR 10 mg every 4 to 6 hours (max 6 doses/day) and were included in the efficacy analyses. The primary endpoint was the sum of pain intensity difference over 5 days (SPID_5-day); secondary endpoints included SPID_2-day and SPID_10-day. The tapentadol IR and oxycodone IR treatment groups showed significant improvements in pain relief as measured by SPID_5-day compared with placebo (P<0.001). The least-squares mean difference of SPID_5-day was similar for tapentadol IR 50 mg (101.2), tapentadol IR 75 mg (97.5), and oxycodone IR 10 mg (111.9). Additionally, tapentadol IR 50 and 75 mg and oxycodone IR 10 mg were significantly superior to placebo based on SPID_2-day and SPID_10-day (P<0.001). Overall, treatment-emergent adverse events were higher in the tapentadol IR 50 mg (52%), tapentadol IR 75 mg (71%), and oxycodone IR 10 mg (84%) groups than placebo (32%). Compared with oxycodone IR 10 mg, both doses of tapentadol IR had lower incidences of reported nausea, (tapentadol IR, ≤21%; oxycodone IR, 41%), vomiting (tapentadol IR, ≤14%; oxycodone IR, 34%), and constipation (tapentadol IR, ≤7%; oxycodone IR, 26%) at similar efficacy. The study findings demonstrate that tapentadol IR 50 and 75 mg provided significant pain relief in patients with pain from end-stage joint disease and had a favorable gastrointestinal tolerability profile compared with oxycodone IR 10 mg. Johnson & Johnson Pharmaceutical Research and Development and Grünenthal GmbH supported this study.