A Comparison of Transdermal Over-the-Counter Lidocaine 3.6% Menthol 1.25%, Rx Lidocaine 5% and Placebo for Back Pain and Arthritis

Abstract

Aim: Transdermal lidocaine therapy has become a gold standard as part of a treatment regimen for patients who suffer from localized pain. We compared transdermal patches: over-the-counter (OTC) lidocaine 3.6% combined with menthol 1.25%, prescription lidocaine 5% (Rx) and placebo. Methods: In a double-blind, placebo-controlled trial, 87 patients were randomized to: OTC, Rx or placebo. Results: OTC met primary end points of noninferiority compared with Rx for efficacy, side effects and quality of life. Versus placebo, OTC proved superiority for efficacy, general activity and normal work. Side effects were similar. Conclusion: It is theorized that menthol’s ability to increase skin permeability facilitated more efficient drug delivery to the site of pain causing higher than expected efficacy. Decreased cost and resource utilization could benefit patients and payers.

KEYWORDS:

• arthritis
• back pain
• lidocaine
• local anesthetic
• osteoarthritis
• patch
• transdermal

Financial & competing interests disclosure

Funding for this study was partially provided by JAR Laboratories, LLC (IL, USA). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Acknowledgements

The authors would like to thank all the patients who volunteered for this study, A Murthy for his assistance with the statistical analysis for this study, N Brinkmann for her assistance in proofreading and editing this manuscript and G Kowalski for her assistance in managing patients in the trial.

Ethical conduct of research

The authors state that this study was conducted in accordance with the Declaration of Helsinki (2008) and the International Conference on Harmonization of Technical Requirements of Pharmaceuticals for Human Use E6 guideline. Approval was obtained from the appropriate Institutional ethics committees, institutional review boards and regulatory authorities, prior to study initiation. Written informed consent was obtained from parent(s)/legal guardian(s) prior to enrollment. For patients of appropriate age and maturity, signed assent forms were obtained in compliance with local laws and regulations.

Additional information

Funding

Funding for this study was partially provided by JAR Laboratories, LLC (IL, USA). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.