Presented at the 2012 AAPM Annual Meeting « Back

The Efficacy and Tolerability of Tapentadol Immediate Release (IR) Versus Oxycodone IR for Moderate to Severe Acute Low Back Pain with Radicular Leg Pain

Charles Oh, MD, coh2@its.jnj.com¹, David M. Biondi, DO², Jim Xiang, PhD¹, Mila Etropolski, MD², (1) Janssen Scientific Affairs, LLC, Raritan, New Jersey, (2) Janssen Scientific Affairs, LLC, Titusville, New Jersey

Introduction: This phase III study (NCT00986180) evaluated efficacy and tolerability of tapentadol IR versus oxycodone IR for moderate-to-severe, acute low back pain (LBP) with radicular leg pain. Materials and Methods: Patients (≥18 years) with acute LBP (intensity ≥5; 11-point NRS) with radicular leg pain were randomized to flexible dosing with tapentadol IR (50, 75, or 100 mg) or oxycodone HCl IR (5, 10, or 15 mg) every 4–6 hours as needed for 10 days. Patients recorded pain intensity twice daily. The primary efficacy endpoint was sum of pain intensity differences (SPID) over 120 hours (SPID120; starting at first study dose); tapentadol IR was considered noninferior to oxycodone IR when the upper bound of the 95% CI for the least-squares mean difference was <120. SPID over 2, 3, and 10 days and 30% and 50% responder rates were evaluated. Treatment-emergent adverse events (TEAEs) were recorded. Patients were recruited from clinical practices; IRB approvals and patient written consents were obtained. Results: Least-squares mean of SPID120 was 264.6 for tapentadol IR (n = 287) and 264.0 for oxycodone IR (n=298; 95% CI, −32.1, 30.9). SPID at 2, 3, and 10 days, and 30% and 50% responder rates at 3, 5, and 10 days were similar between treatment groups. TEAEs (≥10%) with tapentadol IR (n = 321) versus oxycodone IR (n = 324) included vomiting (15.9% vs. 24.7%), nausea (15.9% vs. 20.7%), and dizziness (11.8% vs. 10.5%). Conclusions: Using a flexible-dosing regimen, tapentadol IR was non-inferior to oxycodone IR for relief of acute LBP, with a more favorable gastrointestinal tolerability profile.

Funding: This project was funded by Janssen Scientific Affairs, LLC.