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      Journal of Pain Research (submit here)

      This international, peer-reviewed Open Access journal by Dove Medical Press focuses on reporting of high-quality laboratory and clinical findings in all fields of pain research and the prevention and management of pain. Sign up for email alerts here.

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      Is Open Access

      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

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          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.

          Most cited references20

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          World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

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            Clinical practice: Herpes zoster.

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              Pharmacotherapy for Neuropathic Pain: A Review

              Abstract Neuropathic pain, comprising a range of heterogeneous conditions, is often severe and difficult to manage, and this may result in a chronic condition that negatively affects the overall functioning and quality of life in patients. The pharmacotherapy of neuropathic pain is challenging and for many patients effective treatment is lacking; therefore, evidence-based recommendations are essential. Currently, there is general agreement on which drugs are appropriate for the first-line treatment of neuropathic pain, whereas debate continues regarding second- and third-line treatments. First-line drugs for neuropathic pain include antidepressants (tricyclic antidepressants and serotonin–noradrenaline reuptake inhibitors) and anticonvulsants acting at calcium channels (pregabalin and gabapentin). Second- and third-line drugs for neuropathic pain include topical lidocaine and opioids. Although efficacious in the treatment of neuropathic pain, opioids are not considered to be a first choice because of adverse drug reactions and, more recently, because of concerns about abuse, diversion, and addiction. A clear understanding of the mechanism of action of currently available drugs is an essential step towards an effective clinical approach that aims to tailor therapies both to the specific neuropathic disease and to the needs of an individual patient. This review provides an overview of current drugs available for the treatment of neuropathic pain with an emphasis on their mechanism of action. Funding Pfizer, Italy.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                jpr
                jpainres
                Journal of Pain Research
                Dove
                1178-7090
                23 February 2021
                2021
                : 14
                : 513-526
                Affiliations
                [1 ]Department of Anesthesiology, Rutgers New Jersey Medical School , Newark, NJ, USA
                [2 ]Department of Anesthesiology and Pain Management, Englewood Hospital and Medical Center , Englewood, NJ, USA
                [3 ]Scientific Affairs Neurosciences, PRA Health Sciences , Salt Lake City, UT, USA
                [4 ]Global Research and Development and Medical Affairs, Scilex Pharmaceuticals Inc , Palo Alto, CA, USA
                [5 ]Community Health and Family Medicine, University of Florida Community Health & Family Medicine , Gainesville, FL, USA
                Author notes
                Correspondence: Lynn R Webster Vice President Scientific Affairs, PRA Health Sciences , Salt Lake City, UT, 84103, USATel +1 801 904 4593 Email WebsterLynn@Prahs.com
                Author information
                http://orcid.org/0000-0001-6450-1988
                Article
                287153
                10.2147/JPR.S287153
                7914064
                c0b15f49-477a-4307-83aa-21d447387253
                © 2021 Gudin et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 17 November 2020
                : 16 January 2021
                Page count
                Figures: 4, Tables: 7, References: 29, Pages: 14
                Funding
                Funded by: Scilex Pharmaceuticals Inc;
                This research was supported by Scilex Pharmaceuticals Inc.
                Categories
                Original Research

                Anesthesiology & Pain management
                lidocaine topical system,lidocaine patch,lidocaine medicated plaster,adhesion,postherpetic neuralgia

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