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J Pain Symptom Manage. 2010 Jun;39(6):1053-64. doi: 10.1016/j.jpainsymman.2009.11.316.

Long-term safety of NGX-4010, a high-concentration capsaicin patch, in patients with peripheral neuropathic pain.

Author information

  • 1Department of Neurology, Mount Sinai School of Medicine, New York, New York 10029, USA. david.simpson@mssm.edu

Abstract

CONTEXT:

Postherpetic neuralgia (PHN) and painful human immunodeficiency virus-associated distal sensory polyneuropathy (HIV-DSP) are peripheral neuropathic pain syndromes that are difficult to treat. Current treatment options are often limited by poor tolerability.

OBJECTIVES:

The objective of the current open-label study was to assess the safety of repeated applications of NGX-4010, a high-concentration capsaicin patch (capsaicin 8%), over one year, in patients with moderate to severe PHN or HIV-DSP.

METHODS:

Patients had successfully completed a previous NGX-4010 study and had a pain level appropriate for further treatment. Eligible patients had not been treated with NGX-4010 within 12 weeks of study initiation. Patients received pretreatment with a topical local anesthetic (lidocaine 4%) for 60 minutes followed by either a 60-minute (PHN and HIV-DSP patients) or a 90-minute (HIV-DSP patients) treatment with NGX-4010. Patients could receive up to three additional treatments at intervals of > or = 12 weeks. Regardless of the number of treatments received, all patients were followed up for 48 weeks except for those withdrawing early.

RESULTS:

A total of 106 patients were enrolled and received a total of 293 NGX-4010 treatments. The most frequently reported treatment-emergent adverse events were transient, mild-to-moderate application site erythema, pain, edema, and papules. Small, transient pain-related increases in blood pressure during and immediately after NGX-4010 application were observed. There was no evidence of an increased incidence of adverse events, dermal irritation, intolerability, or impaired neurological function with repeated treatments.

CONCLUSION:

It is concluded that repeated treatments with NGX-4010 administered over a one-year period are generally safe and well tolerated.

Copyright 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

PMID:
20538187
[PubMed - indexed for MEDLINE]
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