Affordable Access

Access to the full text

Open-Label Adhesion Performance Studies of a New Lidocaine Topical System 1.8% versus Lidocaine Patches 5% and Lidocaine Medicated Plaster 5% in Healthy Subjects

Authors
  • Gudin, Jeffrey1, 2
  • Webster, Lynn R3
  • Greuber, Emileigh4
  • Vought, Kip4
  • Patel, Kalpana4
  • Kuritzky, Louis5
  • 1 Rutgers New Jersey Medical School, Newark, NJ
  • 2 Englewood Hospital and Medical Center, Englewood, NJ
  • 3 PRA Health Sciences, Salt Lake City, UT
  • 4 Scilex Pharmaceuticals Inc, Palo Alto, CA
  • 5 University of Florida Community Health & Family Medicine, Gainesville, FL
Type
Published Article
Journal
Journal of Pain Research
Publisher
Dove Medical Press
Publication Date
Feb 23, 2021
Volume
14
Pages
513–526
Identifiers
DOI: 10.2147/JPR.S287153
PMID: 33654425
PMCID: PMC7914064
Source
PubMed Central
Keywords
Disciplines
  • Original Research
License
Green

Abstract

Purpose The primary objective was to evaluate adhesion performance of the lidocaine topical system 1.8% for 12 hours in healthy human subjects in three studies: as a single product (Study 1) and versus other lidocaine topical products (lidocaine patch 5% and lidocaine medicated plaster 5% [Study 2] and generic lidocaine patch 5% [Study 3]). Safety of the lidocaine topical system 1.8%, with a skin irritation focus, was a secondary objective. Patients and Methods All three studies were open-label, randomized, Phase 1 adhesion performance studies in healthy adult volunteers (N=125). Lidocaine topical products were applied for 12 hours per test, per study arm. Adhesion of all test products was scored at 0, 3, 6, 9, and 12 hours post-application. Skin irritation was scored after product removal or when a product detached. Results Overall, the majority (≥75%) of subjects treated with the lidocaine topical system 1.8% demonstrated ≥90% adhesion (FDA adhesion score 0) throughout the 12-hour administration period versus 13.6% of subjects treated with lidocaine patch 5%, 15.9% of subjects treated with lidocaine medicated plaster 5%, and 0% of subjects treated with the generic lidocaine patch 5%. There were no complete detachments with the lidocaine topical system 1.8%, whereas 4.5% of lidocaine patch 5% and lidocaine medicated plaster 5% detached, and 29% of generic lidocaine patch 5% detached. Minimal skin irritation was observed with each lidocaine topical product. Conclusion Across three studies, lidocaine topical system 1.8% demonstrated superior adhesion performance versus the three other products tested. Skin irritation was minimal across products and studies. Clinicaltrials.gov NCT04312750, NCT04320173, NCT04319926.

Report this publication

Statistics

Seen <100 times