Long-term safety of NGX-4010, a high-concentration capsaicin patch, in patients with peripheral neuropathic pain.
J Pain Symptom Manage. 2010 Jun; 39(6):1053-64.JP

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.

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Authors+Show Affiliations

Simpson DM
Department of Neurology, Mount Sinai School of Medicine, New York, New York 10029, USA. david.simpson@mssm.edu
Gazda S
No affiliation info available
Brown S
No affiliation info available
Webster LR
No affiliation info available
Lu SP
No affiliation info available
Tobias JK
No affiliation info available
Vanhove GF
No affiliation info available
NGX-4010 C118 Study Group
No affiliation info available

MeSH

Administration, CutaneousAdolescentAdultAgedAged, 80 and overCapsaicinFemaleHIV InfectionsHumansMaleMiddle AgedNeuralgia, PostherpeticPainPeripheral Nervous System DiseasesTreatment OutcomeYoung Adult

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20538187