A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects
Received 9 November 2019
Accepted for publication 7 March 2020
Published 22 June 2020 Volume 2020:13 Pages 1485—1496
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr E Alfonso Romero-Sandoval
Jeffrey Gudin,1 Charles Argoff,2 Jeffrey Fudin,3 Emileigh Greuber,4 Kip Vought,4 Kalpana Patel,4 Sri Nalamachu5
1Department of Anesthesiology, Englewood Hospital and Medical Center, Englewood, NJ, USA; 2Department of Neurology, Albany Medical Center, Albany, NY, USA; 3Professional Practice, Albany College of Pharmacy and Health Sciences, Albany, NY, USA; 4Scilex Pharmaceuticals Inc., Palo Alto, CA, USA; 5Mid America PolyClinic, Overland Park, KS, USA
Correspondence: Jeffrey Fudin
Professional Practice, Albany College of Pharmacy and Health Sciences, Albany, NY, USA
Tel +1 518-772-4100
Fax +1 518-734-0288
Purpose: This study was designed to characterize drug delivery with lidocaine topical system 1.8% vs lidocaine patch 5% through 2 PK studies.
Patients and Methods: Two Phase 1, single-center, open-label, randomized PK studies were performed in healthy adults. In Study 1, 56 subjects received a single intravenous bolus of 0.7 mg/kg of lidocaine as a lead-in to allow for the accurate determination of apparent dose of both products. After a 7-day washout period, subjects were randomized to receive either lidocaine topical system 1.8% or lidocaine patch 5% for 12 hours followed by another 7-day washout period, after which subjects crossed over to receive the other treatment for 12 hours. In Study 2, 54 subjects were randomized to receive either lidocaine topical system 1.8% or lidocaine patch 5% for 12 hours. After a 7-day washout period, subjects crossed over to receive the other treatment. Adhesion and skin irritation assessments were performed after application of the products in Study 2. In both studies, serial blood samples were collected to measure the plasma concentration of lidocaine after product application. Safety assessments and adverse events were monitored in both studies.
Results: The comparative PK analysis demonstrated that the two products, despite their difference in drug load and strength, are bioequivalent. Both products were well tolerated. In Study 2, dermal response scores (skin tolerability after removal) were similar between lidocaine topical system 1.8% and lidocaine patch 5%, with a mean irritation score per patch < 1 (barely perceptible erythema), which is not considered to be clinically significant.
Conclusion: Bioequivalence was demonstrated between lidocaine topical system 1.8% and lidocaine patch 5%. A comparison of the single-time adhesion scores at 12 hours in Study 2 favored lidocaine topical system 1.8% over lidocaine patch 5%. Both products were well tolerated as a single application in healthy adult human subjects.
ClinicalTrials.gov: NCT04144192, NCT04149938.
Keywords: postherpetic neuralgia, topical, lidocaine, pharmacokinetics
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