Utility of lidocaine as a topical analgesic and improvements in patch delivery systems

References

• Bhala N, Emberson J, Merhi A, et al. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013;382(9894):769–779.
   PubMed Web of Science ®Google Scholar
• Lee WM. Public health: acetaminophen (APAP) hepatotoxicity—isn’t it time for APAP to go away?. J Hepatol. 2017;67:1324–1331.
   PubMed Web of Science ®Google Scholar
• Kumar L, Barker C, Emmanuel A. Opioid-induced constipation: pathophysiology, clinical consequences, and management. Gastroenterol Res Pract. 2014;2014:1–6.
   Web of Science ®Google Scholar
• Bawor M, Dennis BB, Samaan MC, et al. Methadone induces testosterone suppression in patients with opioid addiction. Sci Rep. 2014;4:6189.
   PubMed Web of Science ®Google Scholar
• Brennan MJ. The effect of opioid therapy on endocrine function. Am J Med. 2013;126(Suppl 1):S12–S18.
   PubMed Web of Science ®Google Scholar
• Center for Disease Control. Nonopioid treatments for chronic pain: principals of chronic pain treatment. [cited June 12 2019]. Available from: https://www.cdc.gov/drugoverdose/pdf/nonopioid_treatments-a.pdf
   Google Scholar
• Basbaum AI, Bautista DM, Scherrer G, et al. Cellular and molecular mechanisms of pain. Cell. 2009;139:267–284.
   PubMed Web of Science ®Google Scholar
• Institute of Medicine (US) Committee on Pain, Disability, and Chronic Illness Behavior. Pain and disability: clinical, behavioral, and public policy perspectives. In: Osterweis M, Kleinman A, Mechanic D, editors. The Anatomy and Physiology of Pain. National Academies Press (US); 1987. Chapter 7. [cited 2019 May 30]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK219254/
   Google Scholar
• Sheets MF, Hanck DA. Molecular action of lidocaine on the voltage sensors of sodium channels. J Gen Physiol. 2003;121:163–175.
   PubMed Web of Science ®Google Scholar
• Weinberg L, Peake B, Tan C, et al. Pharmacokinetics and pharmacodynamics of lignocaine: A review. World J Anesthesiol. 2015;4:17–29.
   Google Scholar
• Mick G, Correa-Illanes G. Topical pain management with the 5% lidocaine medicated plaster – a review. Curr Med Res Opin. 2012;28:937–951.
   PubMed Web of Science ®Google Scholar
• Finnerup NB, Haroutounian S. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016;157:1599–1606.
   PubMed Web of Science ®Google Scholar
• Costigan M, Scholz J, Woolf CJ. Neuropathic Pain: A maladaptive response of the nervous system to damage. Annu Rev Neurosci. 2009;32:1–32.
   PubMed Web of Science ®Google Scholar
• Staats PS, Argoff CE, Brewer R, et al. Neuropathic pain: incorporating new consensus guidelines into the reality of clinical practice. Adv Stud Med. 2004;4:S550–S566.
   Google Scholar
• Nalamachu S, Gould EM, Gannaitoni AR. Use of the lidocaine patch 5% in the Treatment of neuropathic pain. J Neuropathic Pain Symptom Palliation. 2006;2:3–13.
   Google Scholar
• Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: systematic review, meta-analysis and updated NeuPSIG recommendations. Lancet Neurol. 2015;14:162–173.
   PubMed Web of Science ®Google Scholar
• Fornasari D. Pharmacotherapy for neuropathic pain: A review. Pain Ther. 2017;6(Suppl 1):S25–S33.
   PubMed Web of Science ®Google Scholar
• Attal N, Cruccu G, Baron R, et al. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 Revision. Eur J Neuro. 2010;17:1113–1123.
   Web of Science ®Google Scholar
• National Institutute for Health and Care Excellence (UK). The pharmacological management of neuropathic pain in adults in non-specialist settings. NICE Clinical Guidelines, No. 173. 2013 (updated Nov). 2018 [cited 2019 Jun 10]. Available from: https://www.nice.org.uk/guidance/cg173
   Google Scholar
• International Association for the Study of Pain. Pharmacological management of neuropathic pain. Pain Clin Updates. 2010;18:1–8.
   Google Scholar
• Moulin DE, Boulanger A, Clark AJ, et al. Consensus statement: pharmacological management of chronic neuropathic pain: revised consensus statement from the Canadian pain society. Pain Res Manag. 2014;18:328–335.
   Google Scholar
• Nalamachu S, Morley-forster P. Diagnosing and managing postherpetic neuralgia. Drugs Aging. 2012;29:863–869.
   PubMed Web of Science ®Google Scholar
• Sampathkumar P, Drage LA, Martin DP. Herpes Zoster (shingles) and postherpetic neuralgia. Mayo Clin Proc. 2009;8:274–280.
   Web of Science ®Google Scholar
• Johnson RW, Rice ASC. Postherpetic neuralgia. N Engl J Med. 2014;371:1526–1533.
   PubMed Web of Science ®Google Scholar
• Dubinsky RM, Kabbani H, El-Chami Z, et al. Practice parameter: treatment of postherpetic neuralgia. An evidence-based report of the quality standards subcommittee of the american academy of neurology. Neurology. 2004;63:959–965.
   PubMed Web of Science ®Google Scholar
• Rowbotham MC, Davies PS, Verkempinck C, et al. Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia. Pain. 1996;65:39–44.
   PubMed Web of Science ®Google Scholar
• Rowbotham MC, Davies PS, Fields HL. Topical lidocaine gel relieves postherpetic neuralgia. Ann Neurol. 1995;37:246–253.
   PubMed Web of Science ®Google Scholar
• Galer BS, Rowbotham MC, Perander J, et al. Topical lidocaine patch relieves postherpetic neuralgia more effectively than a vehicle topical patch: results of an enriched enrollment study. Pain. 1999;80:533–538.
   PubMed Web of Science ®Google Scholar
• Gordh T, Gordh T, Lindqvist K. Lidocaine: the original local anesthetic. Anesthesiology. 2010;113:1433–1437.
   PubMed Web of Science ®Google Scholar
• Endo Pharmaceuticals Inc., Malvern, PA. LIDODERM® Patch Prescribing Information. January, 2015.
   Google Scholar
• Baron R, Allegri M, Correa-Illanes G, et al. The 5% lidocaine-medicated plaster: its inclusion in international treatment guidelines for treating localized neuropathic pain, and clinical evidence supporting its use. Pain Ther. 2016;5:149–169.
   PubMed Web of Science ®Google Scholar
• Scilex Pharmaceuticals. ZTLido™ Prescribing Information. 2018 Apr.
   Google Scholar
• FDA guidance document. Assessing adhesion with transdermal delivery systems and topical patches for ANDAs. Draft Guidance for Industry. Oct, 2018. [cited 2019 Jul 31]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-adhesion-transdermal-delivery-systems-and-topical-patches-andas-draft-guidance-industry
   Google Scholar
• FDA. External analgesic drug products for over-the-counter human use; reopening of the administrative record and amendment of tentative final monograph. Fed. Reg. 42324, July 17, 2003 [cited 2019 Jul 31]. Available from: https://www.federalregister.gov/documents/2003/07/17/03-17934/external-analgesic-drug-products-for-over-the-counter-human-use-reopening-of-the-administrative
   Google Scholar
• Oni G, Brown S, Kenkel J. Comparison of five commonly-available, lidocaine-containing topical anesthetics and their effect on serum levels of lidocaine and its metabolite monoethylglycinexylidide (MEGX). Aesthet Surg J. 2012 May;32(4):495–503.
   PubMed Web of Science ®Google Scholar
• AstraZenaca. EMLA® product monograph. 2017 Aug.
   Google Scholar
• Willhelm IR, Tzabazis A, Likar R, et al. Long-term treatment of neuropathic pain with a 5% lidocaine medicated plaster. Eur J Anaesthesiol. 2010;27:169–173.
   PubMed Web of Science ®Google Scholar
• Navez ML, Monella C, Bosl I, et al. 5% lidocaine medicated plaster for the treatment of postherpetic neuralgia: a review of the clinical safety and tolerability. Pain Ther. 2015;4:1–15.
   PubMed Web of Science ®Google Scholar
• Kesselheim AS, Myers JA, Solomon DH, et al. The prevalence and cost of unapproved uses of top-selling orphan drugs. PLoS ONE. 2012;7:e31894. Epub 2012 Feb 21.
   PubMed Web of Science ®Google Scholar
• Gudin J, Fudin J, Wang E, et al. Treatment patterns and medication use in patients with postherpetic neuralgia. J Manag Care Spec Pharm. 2019 Dec;25(12):1387–1396.
   Google Scholar
• Moore RA, Chi CC, Wiffen PJ, et al. Oral nonsteroidal anti-inflammatory drugs for neuropathic pain. Cochrane Database Syst Rev. 2015;(10):CD010902.
   Google Scholar
• Wolff RF, Bala MM, Westwood M, et al. 5% lidocaine medicated plaster in painful diabetic peripheral neuropathy (DPN): a systematic review. Swiss Med Wkly. 2010;140:297–306.
   PubMed Web of Science ®Google Scholar
• Yang X-D, Fang P-F, Xiang D-X, et al. Topical treatments for diabetic neuropathic pain (review). Exp Ther Med. 2019;17:1963–1976.
   PubMed Web of Science ®Google Scholar
• Baron R, Mayoral V, Leijon G, et al. 5% lidocaine medicated plaster versus pregabalin in post-herpetic neuralgia and diabetic polyneuropathy: an open-label, non-inferiority two-stage random control trial. Curr Med Res Opin. 2009;25:1663–1676.
   PubMed Web of Science ®Google Scholar
• Baron R, Mayoral V, Leijon G, et al. Efficacy and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin in post-herpetic neuralgia and diabetic polyneuropathy. Curr Med Res Opin. 2009;25:1677–1687.
   PubMed Web of Science ®Google Scholar
• Barbano RL, Herrmann DN, Hart-Gouleau S, et al. Effectiveness, tolerability, and impact on quality of life of the 5% lidocaine patch in diabetic polyneuropathy. Arch Neurol. 2004;61:914–918.
   PubMed Web of Science ®Google Scholar
• Argoff CE, Galer BS, Jensen MP. Oleka N and Gammaitoni AR: effectiveness of the lidocaine patch 5% on pain qualities in three chronic pain states: assessment with the neuropathic pain scale. Curr Med Res Opin. 2004;20(Suppl 2):S21–S28.
   PubMed Web of Science ®Google Scholar
• White WT, Patel N. Drass M and Nalamachu S: lidocaine patch 5% with systemic analgesics such as gabapentin: A rational polypharmacy approach for the treatment of chronic pain. Pain Med. 2003;4:321–330.
   PubMed Web of Science ®Google Scholar
• Nalamachu S, Crockett RS, Mathur D. Lidocaine patch 5% for carpal tunnel syndrome: how it compares with injections: A pilot study. J Family Prac. 2006;55:209–214.
   PubMed Web of Science ®Google Scholar
• Nalamachu S, Crockett RS, Gammaitoni AR, et al. A comparison of the lidocaine patch 5% vs Naproxen 500 mg twice daily for the relief of pain associated with carpal tunnel syndrome: A 6-week, randomized, parallel-group study. Medscape J Med. 2006;8(3):33–42.
   Google Scholar
• Moghataderi AR, Jazayeri SM, Azizi S. EMLA cream for carpal tunnel syndrome: how it compares with steroid injection. Electromyogr Clin Neurophysiol. 2009;49:287–289.
   PubMedGoogle Scholar
• Baron R, Binder A, Attal N, et al. Neuropathic low back pain in clinical practice. Eur J Pain. 2016;20:861–873.
   PubMed Web of Science ®Google Scholar
• Galer BS, Gammaitoni AR, Olekai N, et al. Use of the Lidocaine patch 5% in reducing intensity of various pain qualities reported by patients with lower back pain. Curr Med Res Opin. 2004;20(Suppl 2):S5–S12.
   PubMed Web of Science ®Google Scholar
• Gimbel J, Linn R, Hale M, et al. Lidocaine patch treatment in patients with low back pain: results of an open-label, nonrandomized pilot study. Am J Ther. 2005 Jul-Aug;12(4):311–319.
   PubMedGoogle Scholar
• Galer BS, Sheldon E, Patel N, et al. Topical lidocaine patch 5% may target a novel underlying pain mechanism in osteoarthritis. Curr Med Res Opin. 2004;20:1455–1458.
   PubMed Web of Science ®Google Scholar
• Burch F, Codding C, Patel N, et al. Lidocaine patch 5% improves pain, stiffness, and physical function in osteoarthritis pain patients. A prospective, multicenter, open-label effectiveness trial. Osteoarthritis Cartilage. 2004;12:253–255.
   PubMed Web of Science ®Google Scholar
• Gammaitoni AR, Galer BS, Onawola R, et al. Lidocaine patch 5% and its positive impact on pain qualities in osteoarthritis: results of a pilot 2-week,open-label study using the neuropathic pain scale. Curr Med Res Opin. 2004;20(Suppl 2):S13–19.
   PubMed Web of Science ®Google Scholar
• FDA.gov. FYs 2013-2017 GDUFA science and research report: transdermal drug products. 2018 [cited 2019 Feb 13]. Available from: https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm605293.htm
   Google Scholar
• Patel K, Gudin JA, Vought K, et al. A randomized, comparative pharmacokinetic (PK) study of ZTLIDO™ lidocaine topical system 18% (36 mg) versus LIDODERM® lidocaine patch 5% (700 mg). Presented at PAINWeek; 2018 Sep 5–8; Las Vegas, NV.
   Google Scholar
• FDA adverse events reporting system 9FAERS public dashboard. Data as of December 31. 2018 [cited 2019 Feb 13]. Available from: https://www.fda.gov/drugs/fda-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-latest-quarterly-data-files
   Google Scholar
• Gudin J, Nalamachu S, Argoff C, et al. Adhesion performance of 3 lidocaine patch formulations. Presented at PAINWeek; 2018 Sept 5–8; Las Vegas, NV.
   Google Scholar
• Scilex Corporation. Presentation to the securities and exchange commission. SEC Archives. 2019 Apr. [cited 2019 Jul 31]. Available from: https://www.sec.gov/Archives/edgar/data/850261/000114420419019578/tv518886_ex99-1.htm (Slides 10 and 11)
   Google Scholar
• Mylan Pharmaceuticals, Inc. Lidocaine patch prescribing information. 2018 Nov.
   Google Scholar