Tapentadol Prolonged Release Versus Strong Opioids for Severe, Chronic Low Back Pain: Results of an Open-Label, Phase 3b Study

Abstract

Introduction: This open-label, phase 3b study

A Randomized Withdrawal, Placebo-Controlled Study Evaluating the Efficacy and Tolerability of Tapentadol Extended Release in Patients With Chronic Painful Diabetic Peripheral Neuropathy

“…In the current study, tapentadol ER (100-250 mg bid) was associated with significantly greater improvements than placebo (P # 0.05 for all) in the total and subscale scores of the NPSI, a valid and sensitive tool for assessing the effects of treatment on neuropathic pain components (13); these results support the efficacy of tapentadol ER for the relief of neuropathic pain-specific symptoms. In separate, phase 3b studies of tapentadol ER (50-250 mg bid) for the management of moderate to severe chronic low back pain with or without a neuropathic pain component (based on the painDETECT questionnaire), improvements from baseline over the course of the study were observed not only in pain intensity but in measures of anxiety (31,32), depression (31,32), and sleep quality (31,32) for patients with a neuropathic pain component. This is the second placebo-controlled trial using a randomized withdrawal design demonstrating that tapentadol ER (100-250 mg bid) is well tolerated and effective for the management of neuropathic pain associated with DPN in adults.…”

Practical Considerations for the Use of Tapentadol Prolonged Release for the Management of Severe Chronic Pain

“…Because of tapentadol's favorable tolerability profile, it may be possible to titrate tapentadol PR to doses above the equianalgesic doses of previous opioids, thereby offering the potential for added analgesia. The successful rotation of patients from previous strong (WHO step III) opioids to tapentadol PR has been reported in 2 recent Phase IIIb studies 45,56 in patients with severe chronic low back pain or osteoarthritis pain who had responded to WHO step III opioids but showed poor tolerability. The starting doses in these 2 studies 45,56 were based on the morphine equivalent doses of all previous opioids used ( Table IV.…”

“…The successful rotation of patients from previous strong (WHO step III) opioids to tapentadol PR has been reported in 2 recent Phase IIIb studies 45,56 in patients with severe chronic low back pain or osteoarthritis pain who had responded to WHO step III opioids but showed poor tolerability. The starting doses in these 2 studies 45,56 were based on the morphine equivalent doses of all previous opioids used ( Table IV. 45 Although the number of patients used to determine each of these equianalgesic ratios was relatively small, the equianalgesic ratio determined for tapentadol PR to oxycodone CR in this Phase IIIb study 45 was in line with that observed in a pooled analysis of data from randomized, double-blind, placebo-and activecontrolled, Phase III studies comparing tapentadol PR and oxycodone CR, 29 and was confirmed in a second Phase IIIb study of similar design.…”

“…33 A more rapid titration schedule may be considered for patients with uncontrolled pain. 37,38,45,56 The recommended dose range of tapentadol PR is 50 to 250 mg BID; daily doses of 4500 mg of tapentadol PR are not recommended. 33 Tapentadol PR is available in 50-, 100-, 150-, 200-, and 250-mg dose strengths.…”

“…Tapentadol PR has also been associated with improvements in neuropathic pain symptoms and quality of life in patients with neuropathic pain, 37,45 which are not consistently observed with classic opioid treatments. [46][47][48][49][50][51] The broad effectiveness of tapentadol PR for nociceptive, neuropathic, and mixed types of chronic pain, which is likely due to its combination of MOR agonism and NRI activities, 18,19 may simplify chronic pain treatment by eliminating the need to isolate and treat the individual types of chronic pain with a combination of different analgesics and coanalgesics. Tapentadol PR may also facilitate chronic pain management because tapentadol is associated with a low risk of pharmacokinetic interactions, 20,21 making it a viable option for poly-medicated patients, including elderly patients.…”