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ICMTNP: Lidocaine Patch Effective In Relieving Nerve Pain After Shingles WASHINGTON, DC -- June 4, 1999 -- The use of a topical lidocaine patch was significantly effective in the treatment of the pain associated with postherpetic neuralgia (PHN), a chronic pain disorder following acute herpes zoster (shingles), according to the results of a new clinical study. The study compared the efficacy of Hind Health Care’s Lidoderm(R) patch (lidocaine patch 5%) versus placebo patches applied directly to the painful skin of people with PHN. Results of the study were presented today during the second International Conference on Mechanisms and Treatment of Neuropathic Pain in Washington, D.C., by lead investigator Bradley Galer, MD, director of clinical studies, Institute for Education and Research in Pain and Palliative Care, and co-director, Program for Pain Due to Nerve Injury, Beth Israel Medical Center in New York. "This study found that patients suffering from postherpetic neuralgia obtain significantly more relief from pain from a topical adhesive patch impregnated with lidocaine than from application of a non-medicated placebo patch," Dr. Galer said. Study participants had all previously been treated with topical lidocaine patches on a regular basis for at least one month prior to study enrolment and were using the lidocaine patch at home with at least moderate pain relief from the patch. Subjects were then enrolled in a two-treatment period study where they were treated with a placebo patch for one phase and the lidocaine patch for the other. The primary efficacy variable in the study was time to exit-- that is, subjects' time in each of the two study phases were compared (subjects were allowed to exit either treatment phase if their pain worsened by a set amount as compared to their pre-study pain levels). The results demonstrated that the lidocaine patch was superior to the placebo patch in alleviating the pain of postherpetic neuralgia. The median time to exit with the lidocaine patch treatment phase was greater than 14 days, whereas the placebo patch exit time was only 3.8 days. Seventy-eight percent of the treatment subjects preferred the treatment phase in which the lidocaine patch was applied and 90 percent of the patients in this study reported moderate or greater pain relief for at least five treatment days with the lidocaine patches. This study was a double-blind, balanced-random assignment, placebo controlled, two period cross-over trial of 28 days maximum duration. Thirty-two patients participated in the study. "More effective and better-tolerated therapies for PHN are greatly needed and topical lidocaine patches appear to offer a solution," Dr. Galer said. "This topical lidocaine patch, Lidoderm, for the treatment of PHN provides several distinct advantages over currently used oral agents, such as the tricyclic antidepressants, anticonvulsants and opiates. "The patch does not cause any systemic side effects, does not require dose titration and is simple to use. Due to its proven efficacy in trials and its safety profiles, topical lidocaine patches should be considered as a first-line therapy for PHN, especially for the elderly.” Postherpetic neuralgia results from nerve injury or damage during an outbreak of shingles, a reactivation of the herpes zoster virus that causes chicken pox. PHN causes chronic, often excruciating pain that persists for months or even years in the sensory nerves where the shingles eruption occurred. PHN has long been considered a difficult to treat pain condition. Approximately one million patients contract shingles annually in the U.S. Almost all shingles patients experience pain and as many as 20 percent develop long-term pain. The elderly are the most likely to develop PHN -- over half of shingles patients over age 60 and 75 percent of patients over age 70 experience long-term pain. Lidoderm is composed of an adhesive material containing 5% lidocaine that is applied to a non-woven polyester felt backing. When applied to intact skin, Lidoderm provides dermal analgesia by the release of lidocaine from the patch into the epidermal and dermal layers of the skin. The patch provides analgesic action, reducing pain at the damaged and dysfunctional nerves, without the complete loss of sensation or numbness. Lidoderm was approved by the U.S. Food and Drug Administration in March 1999 as the only treatment specifically for the pain associated with PHN. E-mail this page to a friend or colleague! To print, use this version