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.

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. 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. 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. 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. NCT04312750, NCT04320173, NCT04319926.

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© 2021 Gudin et al.

Déclaration de conflit d'intérêts

Dr. Gudin has been an advisor, consultant, speaker bureau member, or shareholder in the past year for Averitas Pharma, BioDelivery Sciences International, Inc., Daiichi Sankyo, Hisamitsu Pharmaceutical Co. Inc., Nektar, Quest Diagnostics, Salix Pharmaceuticals, Scilex Pharmaceuticals Inc., and Virpax Pharmaceuticals. Dr. Webster is affiliated with PRA Health Sciences and has been an advisor or consultant for Alcobra, BioDelivery Sciences International, Inc., Bonti, Charleston Laboratories, Daiichi Sankyo, Depomed, Egalet, Elysium Pharmaceuticals, Ensysce Biosciences, Indivior, Inspirion Pharmaceuticals, Insys Therapeutics, Jefferies, KemPharm, Mallinckrodt Pharmaceuticals, Merck, Neurana, Pain Therapeutics, Pernix, Pfizer, Salix, Shionogi, Teva, Trevena, Trevi Therapeutics, Vallon, and Vector Pharma. Drs. Greuber, Vought, and Patel are employees of Scilex Pharmaceuticals Inc. Dr. Kuritzky has no relationships to disclose; the opinions in this article do not represent those of his institutional affiliation (University of Florida). The authors report no other conflicts of interest in this work.