Effectiveness of Tapentadol Prolonged Release (<scp>PR</scp>) Compared with Oxycodone/Naloxone <scp>PR</scp> for the Management of Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open‐Label, Phase 3b/4 Study

Abstract

The study was formally shown to be positive and demonstrated, in the primary effectiveness endpoint, the noninferiority for tapentadol PR vs. oxycodone/naloxone PR. The effectiveness of tapentadol PR was superior to that of oxycodone/naloxone PR by means of clinical relevance and statistical significance (confirmatory evidence of superiority). Tapentadol PR was associated with significantly greater improvements in neuropathic pain-related symptoms and global health status than oxycodone/naloxone PR and with a significantly better gastrointestinal tolerability profile. Tapentadol PR may be considered a first-line option for managing severe chronic low back pain with a neuropathic pain component.