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Tolerability of NGX-4010, a capsaicin 8% dermal patch, following pretreatment with lidocaine 2.5%/prilocaine 2.5% cream in patients with post-herpetic neuralgia

Authors
  • Webster, Lynn R1
  • Nunez, Margarita2
  • Tark, Marvin D3
  • Dunteman, Edwin D4
  • Lu, Biao5
  • Tobias, Jeffrey K5
  • Vanhove, Geertrui F5
  • 1 Lifetree Clinical Research, Salt Lake City, UT, USA , Salt Lake City (United States)
  • 2 Comprehensive NeuroScience, Inc, St. Petersburg, FL, USA , St. Petersburg (United States)
  • 3 Drug Studies America, Marietta, GA, USA , Marietta (United States)
  • 4 A & A Pain Institute of St. Louis, St. Louis, MO, USA , St. Louis (United States)
  • 5 NeurogesX, Inc, San Mateo, CA, USA , San Mateo (United States)
Type
Published Article
Journal
BMC Anesthesiology
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Dec 19, 2011
Volume
11
Issue
1
Identifiers
DOI: 10.1186/1471-2253-11-25
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundPost-herpetic neuralgia (PHN) is a common type of neuropathic pain that can severely affect quality of life. NGX-4010, a capsaicin 8% dermal patch, is a localized treatment that can provide patients with significant pain relief for up to 3 months following a single 60-minute application. The NGX-4010 application can be associated with application-site pain and in previous clinical trials pretreatment with a topical 4% lidocaine anesthetic was used to enhance tolerability. The aim of the current investigation was to evaluate tolerability of NGX-4010 after pretreatment with lidocaine 2.5%/prilocaine 2.5% anesthetic cream.MethodsTwenty-four patients with PHN were pretreated with lidocaine 2.5%/prilocaine 2.5% cream for 60 minutes before receiving a single 60-minute application of NGX-4010. Tolerability was assessed by measuring patch application duration, the proportion of patients completing over 90% of the intended treatment duration, application site-related pain using the Numeric Pain Rating Scale (NPRS), and analgesic medication use to relieve such pain. Safety was assessed by monitoring adverse events (AEs) and dermal irritation using dermal assessment scores.ResultsThe mean treatment duration of NGX-4010 was 60.2 minutes and all patients completed over 90% of the intended patch application duration. Pain during application was transient. A maximum mean change in NPRS score of +3.0 was observed at 55 minutes post-patch application; pain scores gradually declined to near pre-anesthetic levels (+0.71) within 85 minutes of patch removal. Half of the patients received analgesic medication on the day of treatment; by Day 7, no patients required medication. The most common AEs were application site-related pain, erythema, edema, and pruritus. All patients experienced mild dermal irritation 5 minutes after patch removal, which subsequently decreased; at Day 7, no irritation was evident. The maximum recorded dermal assessment score was 2.ConclusionNGX-4010 was well tolerated following pretreatment with lidocaine 2.5%/prilocaine 2.5% cream in patients with PHN. The tolerability of the patch application appeared comparable with that seen in other studies that used 4% lidocaine cream as the pretreatment anesthetic. This study is registered at http://www.clinicaltrials.gov as number NCT00916942.

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