Effectiveness and Tolerability of a Moderate Dose of Tapentadol Prolonged Release for Managing Severe, Chronic Low Back Pain with a Neuropathic Component: An Open‐label Continuation Arm of a Randomized Phase 3b Study

Objective To evaluate the effectiveness and tolerability of tapentadol prolonged release ( PR ) for severe, chronic low back pain with a neuropathic component in a subpopulation that achieved adequate pain relief with tapentadol PR 300 mg/day in a randomized, double‐blind, phase 3b study. Methods Patients with pain DETECT “unclear” or “positive” ratings and pain intensity ≥ 6 (11‐point NRS ‐3 [average 3‐day pain intensity]) were titrated to tapentadol PR 300 mg/day over 3 weeks. A subpopulation with pain intensity < 4 continued receiving tapentadol PR 300 mg/day during an 8‐week, open‐label continuation arm. For the primary study population, patients with ≥ 1‐point decrease from baseline and pain intensity ≥ 4 were randomized to tapentadol PR 500 mg/day or tapentadol PR 300 mg/day plus pregabalin 300 mg/day during a concurrent 8‐week, double‐blind comparative period. Results From baseline to end of titration and to final evaluation, significant improvements were observed in pain intensity (mean [ SD ] changes from baseline to: end of titration; − 5.3 [1.78]; final evaluation; − 5.2 [2.39]; both P  <   0.0001), neuropathic pain symptoms, and quality‐of‐life measures in the open‐label continuation arm, with greater improvements in this selected subpopulation than in either group in the primary study population. A favorable tolerability profile was observed, with incidences of all individual treatment‐emergent adverse events ≤ 5.1% during the continuation period. Conclusions A subpopulation of patients with low back pain with a neuropathic component responded very well to tapentadol PR 300 mg/day, with significant improvements in pain intensity, neuropathic pain‐related symptoms, and quality of life. Further research is needed to identify factors associated with a very positive treatment response.