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Related Experiment Video

Updated: Jun 16, 2026

Treating Low Back Pain in Failed Back Surgery Patients with Multicolumn-lead Spinal Cord Stimulation

Treating Low Back Pain in Failed Back Surgery Patients with Multicolumn-lead Spinal Cord Stimulation

Published on: June 26, 2018

Dose conversion between tapentadol immediate and extended release for low back pain.

Mila S Etropolski¹, Akiko Okamoto, Douglas Y Shapiro

¹Johnson & Johnson Pharmaceutical Research & Development, CNS/Pain, Titusville, NJ 08560, USA. metropol@its.jnj.com

|February 2, 2010

Summary

Tapentadol immediate-release (IR) and extended-release (ER) formulations offer equivalent pain relief for chronic low back pain. Direct conversion between tapentadol IR and ER is safe and effective, allowing for flexible patient management.

Related Experiment Videos

Last Updated: Jun 16, 2026

Treating Low Back Pain in Failed Back Surgery Patients with Multicolumn-lead Spinal Cord Stimulation

Treating Low Back Pain in Failed Back Surgery Patients with Multicolumn-lead Spinal Cord Stimulation

Published on: June 26, 2018

Area of Science:

Pharmacology
Pain Management
Clinical Trials

Background:

Tapentadol, a dual-acting analgesic (mu-opioid receptor agonist and norepinephrine reuptake inhibitor), exists in immediate-release (IR) and extended-release (ER) forms.
Understanding safety and equianalgesic ratios for switching between tapentadol IR and ER is crucial for clinical practice.

Purpose of the Study:

To evaluate the direct conversion of total daily dose (TDD) between tapentadol IR and ER.
To assess the equivalence in efficacy and safety when switching between tapentadol formulations.

Main Methods:

A randomized, double-blind, 2-period crossover study involving 13 US centers.
Patients with moderate to severe chronic low back pain were initially stabilized on tapentadol IR.
Patients were then randomized to receive either tapentadol IR or tapentadol ER for two 2-week periods, with a primary endpoint of average daily pain intensity.

Main Results:

No significant difference in mean average daily pain intensity between tapentadol IR (3.9) and tapentadol ER (4.0) was observed (difference = 0.1; 95% CI, -0.09 to 0.28).
The median TDD for both formulations was 300 mg.
Treatment-emergent adverse events were similarly distributed between the tapentadol IR and ER groups.

Conclusions:

Tapentadol IR and ER formulations provide equivalent analgesic efficacy for chronic low back pain.
Direct conversion between tapentadol IR and ER is supported due to comparable efficacy and safety profiles.
This allows for flexible switching between formulations based on patient needs.