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To evaluate healthcare resource utilization (HCRU) by osteoarthritis (OA) pain severity.Cross-sectional surveys of US physicians and their patients were conducted between February and May 2017. Using the Numeric Rating Scale, patients were classified by self-reported pain intensity in the last week into mild (0-3), moderate (4-6), and severe (7-10) cohorts. Parameters assessed included clinical characteristics, HCRU, and current caregiver support. Descriptive statistics were obtained, and analysis of variance and chi-square tests were performed.Patients (n = 841) were mostly female (60.9%) and white (77.8%), with mean age of 64.6 years. Patients reported mild (45.4%), moderate (35.9%), and severe (18.7%) OA pain. Mean number of affected joints varied by pain severity (range mild: 2.7 to severe: 3.6;Greater current pain was associated with more prior HCRU including imaging for monitoring progression, HCP visits including more specialty care, hospitalizations, surgery/planned surgery, and loss of independence due to functional disability. Yet rates of hospitalizations and X-ray use were still sizable even among patients with mild pain. These cross-sectional findings warrant longitudinal assessment to further elucidate the impact of pain on HCRU.

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

Interest in and use of topical analgesics has been increasing, presumably due to their potential utility for relief of acute and chronic pain. Topically applied agents with analgesic properties can target peripheral nociceptive pathways while minimizing absorption into the plasma that leads to potential systemic adverse effects.Clinical trials have found 5% lidocaine patches to be effective and well tolerated for the treatment of post-herpetic neuralgia (PHN) with a minimal risk of toxicity or drug-drug interactions. With this patch formulation, the penetration of lidocaine into the skin produces an analgesic effect without producing a complete sensory block. Use of topical lidocaine is supported by clinical practice guidelines, including first-line treatment by the American Academy of Neurology (guidelines retired 2018), the European Federation of Neurological Societies and second-line by the Canadian Pain Society.FDA approved 5% lidocaine patches in 1999, and a 1.8% topical lidocaine system in 2018 - both indicated for the treatment of pain secondary to PHN. The 1.8% system offers a more efficient delivery of lidocaine that is bioequivalent to 5% lidocaine patches, but with a 19-fold decrease in drug load (i.e., 36 mg versus 700 mg) as well as superior adhesion that allows the patch to maintain contact with the skin during the 12-h administration period.Although topical lidocaine formulations have advanced over time and play an important role in the treatment of PHN, a variety of other conditions that respond to topical lidocaine have been reported in the literature including PHN, lower back pain, carpal tunnel syndrome, diabetic peripheral neuropathy, and osteoarthritis joint pain. Other neuropathic or nociceptive pain syndromes may respond to topical lidocaine in select cases and warrant further study. Clinicians should consider local anesthetics and other topical agents as part of their multimodal treatments of acute and chronic pain.

Introduction: Postherpetic neuralgia (PHN) is associated with moderate to severe pain with peripheral and central mechanisms. While there is no clear-cut first-line therapeutic approach to PHN pain control, lidocaine patches are frequently used as monotherapy or part of a multimodal pain regimen. Methods: An online survey, the first of its kind, was conducted among PHN patients (n = 153) and nurses (n = 151) in order to determine clinical and patient knowledge, attitudes and practices toward the lidocaine patch and current unmet needs. Results: Results of the survey indicated that PHN patients are prescribed a mean of 2.6 medications to control their PHN pain, including the lidocaine patch. There were negative responses related to the patches’ ability to adhere to the skin. Patients reported the use of tape to hold the patches in place and/or patches that detached completely, truncating the therapeutic dose period. Most nurses (53%) found the biggest obstacle to PHN pain control was noncompliance and 98% stated that reliable patch adhesion for the intended 12-hour application was “somewhat important” or “very important” for PHN pain control. Forty-five percent of nurses said that poor patient adherence to PHN analgesic regimens was related to poor adhesion of the lidocaine patch. Conclusion: A new bioequivalent lidocaine patch has been developed with better adhesive characteristics, nine-fold greater bioavailability, and improved form factor.

Jeffrey Fudin,1– 4 Erica L Wegrzyn,1– 3 Emileigh Greuber,5 Kip Vought,5 Kalpana Patel,5 Sri Nalamachu6 1Samuel Stratton Department of Veterans Affairs Medical Center, Albany, NY, USA; 2Albany College of Pharmacy & Health Sciences, Albany, NY, USA; 3Western New England University College of Pharmacy, Springfield, MA, USA; 4Remitigate, LLC, Delmar, NY, USA; 5Scilex Pharmaceuticals Inc., Mountain View, CA, USA; 6Mid America PolyClinic, Overland Park, KS, USACorrespondence: Jeffrey FudinRemitigate, LLC, Delmar, NY 12054, USATel +1 518-772-4100Fax +1 518-734-0288Email jeff@paindr.comPurpose: This study compares the pharmacokinetic (PK) profile, adhesion, and safety of lidocaine topical system 1.8%, a novel lidocaine topical system approved to treat postherpetic neuralgia, under conditions of heat and exercise vs normal conditions.Materials and Methods: This open-label, 3-period, 3-treatment crossover study randomized 12 healthy adults to receive three lidocaine topical systems 1.8% during each of three treatment periods, with 7-day washouts between treatments. The product was applied to the mid-lower back and was removed after 12 hours. During Treatment A, subjects exercised on a bicycle for 30 minutes at 0, 2.5, 5.5, and 8.5 hours. During Treatment B, heat (temperature set at 36.7– 40.3°C) was applied at 0 and 8.5 hours. Treatment C was normal conditions. The PK profile of each subject under exercise and heat conditions was compared to normal conditions. Skin irritation, adhesion, and adverse events were assessed.Results: Twelve subjects completed the study. Exposure to external heat resulted in increased peak plasma concentration of lidocaine with a mean Cmax of 160.3± 100.1 ng/mL vs 97.6± 36.9 ng/mL under normal conditions, with no effect on the extent of exposure (AUC). Concentrations returned to normal within 4 hours after the heat was removed. No clinically relevant differences in absorption were observed under exercise conditions with a mean Cmax of 90.5± 25.4 ng/mL and no effect on the extent (AUC) of lidocaine exposure was observed relative to normal conditions. No systems detached during the study. Adverse events were mild, with none leading to discontinuation.Conclusion: Transient heat exposure resulted in increased lidocaine plasma concentrations compared to normal conditions, whereas exercise had no effect. The effects of heat appear to be immediate, reversible, and below systemic therapeutic threshold in antiarrhythmic treatment (1000– 1500 ng/mL), and well below the safe systemic threshold of 5000 ng/mL. Lidocaine topical system 1.8% remained adhered to the skin and was well tolerated under all conditions. ClinicalTrials.gov: NCT04150536.Keywords: herpes zoster, shingles, neuropathic pain, dermal

Chronic regional pain syndrome (CRPS) is a neuropathic pain syndrome that involves both peripheral and central sensitization. Described in the literature as early as 1872, CRPS has been described using different names and different symptoms over the years. Since many neuropathic pain syndromes are rare, complex, and exhibit overlapping signs and symptoms, diagnosing CRPS has been challenging. Recently the Orlando Criteria in 1993, the subsequent Budapest Criteria in 2003 have attempted to provide a more helpful and robust diagnostic framework. However, the multiplicity of signs and symptoms and allowable variations have resulted in a diagnostic template that accommodates what may actually be a wide variety of conditions and obscures a better understanding of CRPS. The Budapest Criteria make CRPS ultimately a diagnosis of exclusion, leaving clinicians with patients who may be CRPS Type I, CRPS Type II or the new CRPS-NOS. CRPS can be challenging to treat and many treatments are ineffective, possibly owing to the fact that the syndrome is currently defined in such a diffuse way. The current diagnostic criteria of CRPS have even called the entire syndrome into question. There is an urgent need to better define and describe CRPS so that it can be appropriately diagnosed and its mechanisms elucidated. That step will lead to better treatment.