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      A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects

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          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.


          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.


          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.


          NCT04144192, NCT04149938.

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          Most cited references 11

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          Post-herpetic Neuralgia: a Review.

          Post-herpetic neuralgia (PHN) is a chronic neuropathic pain condition that persists 3 months or more following an outbreak of shingles. Shingles, also known as acute herpes zoster, is associated with the reactivation of the dormant varicella zoster virus in an individual who has experienced chicken pox. PHN is associated with persistent and often refractory neuropathic pain. Patients may experience multiple types of pain including a constant deep, aching, or burning pain; a paroxysmal, lancinating pain; hyperalgesia (painful stimuli are more painful than expected); and allodynia (pain associated with typically non-painful stimuli). The pharmacological treatment of PHN may include a variety of medications including alpha-2 delta ligands (gabapentin and pregabalin), other anticonvulsants (carbamazepine), tricyclic antidepressants (amitriptyline, nortriptyline, doxepin), topical analgesics (5 % lidocaine patch, capsaicin) tramadol, or other opioids. The considerable side effect profiles of the commonly used oral medications often limit their practical use, and a combination of both topical and systemic agents may be required for optimal outcomes. Physicians and other treatment providers must tailor treatment based on the response of individual patients.
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            Practical considerations in the pharmacological treatment of postherpetic neuralgia for the primary care provider

            An estimated one million individuals in the US are diagnosed with herpes zoster (HZ; shingles) each year. Approximately 20% of these patients will develop postherpetic neuralgia (PHN), a complex HZ complication characterized by neuropathic pain isolated to the dermatome that was affected by the HZ virus. PHN is debilitating, altering physical function and quality of life, and commonly affects vulnerable populations, including the elderly and the immunocompromised. Despite the availability of an immunization for HZ prevention and several approved HZ treatments, the incidence of PHN is increasing. Furthermore, management of the neuropathic pain associated with PHN is often suboptimal, and the use of available therapeutics may be complicated by adverse effects and complex, burdensome treatment regimens, as well as by patients’ comorbidities and polypharmacy, which may lead to drug–drug interactions. Informed and comprehensive assessments of currently available pharmacological treatment options to achieve effective pain control in the primary care setting are needed. In this article, we discuss the situation in clinical practice, review currently recommended prevention and treatment options for PHN, and outline practical considerations for the management of this neuropathic pain syndrome, with a focus on optimal, individual-based treatment plans for use in the primary care setting.
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              Efficacy and tolerability of a 5% lidocaine medicated plaster for the topical treatment of post-herpetic neuralgia: results of a long-term study.

              Evaluation of long-term efficacy and safety of the 5% lidocaine medicated plaster for neuropathic pain symptoms in patients with post-herpetic neuralgia (PHN). Design - a 12-month, open-label, phase III study with an open-label extension conducted at 34 outpatient clinics in 12 European countries. Patients - aged >or=50 years, newly recruited (average pain intensity >or=4) or pre-treated with the 5% lidocaine medicated plaster in a previous study. Interventions - application of up to three 5% lidocaine medicated plasters dependent upon size of the painful area for up to 12 hours per day. Outcome measures - efficacy measures included patients' recall of pain relief and pain intensity in the previous week. Adverse events (AEs) were also reported. 249 patients participated in the 12-month study, 247 were analysed (full analysis set, FAS). Newly recruited patients had a mean average pain intensity (11-point numerical rating scale [NRS]) of 5.9 +/- 1.4 at baseline, which decreased to 3.9 +/- 1.6 at week 12 and remained stable at 3.9 +/- 2.3 until the end of the 12-month study. In pre-treated patients, pain intensity decreased further from baseline (3.9 +/- 1.9) to study end (3.4 +/- 2.0). Pain relief values were consistent with pain intensity reductions and were sustained in patients continuing treatment in the extension phase (mainly >or=24 months treatment in total). The most common AEs tended to be infections such as bronchitis and nasopharyngitis. Forty-eight drug-related adverse events (DRAEs), mainly mild to moderate localised skin reactions, occurred in 31 (12.4%) patients in the first 12 months. The profile of DRAEs was similar in the extension phase. This study suggests that long-term treatment with the 5% lidocaine medicated plaster may provide substantial and maintained reductions in pain intensity, and that it is continuously well tolerated in patients suffering from peripheral neuropathic pain associated with previous herpes zoster infection. These findings support the use of the 5% lidocaine medicated plaster as one of the first-line therapies in this population.

                Author and article information

                J Pain Res
                J Pain Res
                Journal of Pain Research
                22 June 2020
                : 13
                : 1485-1496
                [1 ]Department of Anesthesiology, Englewood Hospital and Medical Center , Englewood, NJ, USA
                [2 ]Department of Neurology, Albany Medical Center , Albany, NY, USA
                [3 ]Professional Practice, Albany College of Pharmacy and Health Sciences , Albany, NY, USA
                [4 ]Scilex Pharmaceuticals Inc ., Palo Alto, CA, USA
                [5 ]Mid America PolyClinic , Overland Park, KS, USA
                Author notes
                Correspondence: Jeffrey Fudin Professional Practice, Albany College of Pharmacy and Health Sciences , Albany, NY, USATel +1 518-772-4100Fax +1 518-734-0288 Email jeff@paindr.com
                © 2020 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).

                Page count
                Figures: 3, Tables: 11, References: 20, Pages: 12
                Original Research

                Anesthesiology & Pain management

                postherpetic neuralgia, topical, lidocaine, pharmacokinetics


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