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NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study.
Lancet Neurol. 2008 Dec; 7(12):1106-12.LN

Abstract

BACKGROUND

The limitations of current treatments for postherpetic neuralgia (PHN) have led to the investigation of localised, non-systemic alternatives. NGX-4010, a high-concentration (8%) capsaicin dermal patch, was developed to treat patients with neuropathic pain. We report the results of a randomised, double blind, 12-week study of the efficacy and safety of one application of NGX-4010 in patients with PHN.

METHODS

In this multicentre, double-blind, parallel-group trial, 402 patients were randomly assigned to one 60-min application of NGX-4010 (640 microg/cm(2) [8% capsaicin]) or a low-concentration capsaicin control patch (3.2 microg/cm(2) [0.04% capsaicin]). Patients were aged 18-90 years, had had postherpetic neuralgia for at least 6 months, and had an average baseline numeric pain rating scale (NPRS) score of 3 to 9. The primary efficacy endpoint was percentage change in NPRS score from baseline to weeks two to eight. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00115310.

FINDINGS

Patients who were randomly assigned to NGX-4010 (n=206) had a significantly greater reduction in pain during weeks two to eight than did patients who had the control patch (n=196). The mean changes in NPRS score were -29.6%vs -19.9% (difference -9.7%, 95% CI -15.47 to -3.95; p=0.001). 87 (42%) patients who received NGX-4010 and 63 (32%) controls had a 30% or greater reduction in mean NPRS score (odds ratio [OR] 1.56, 95% CI 1.03 to 2.37; p=0.03). The patients who had NGX-4010 had significant improvements in pain during weeks two to 12 (mean change in NPRS score -29.9%vs -20.4%, difference -9.5, -15.39 to -3.61; p=0.002). Transient blood pressure changes associated with changes in pain level were recorded on the day of treatment, and short-lasting erythema and pain at the site of application were common, self-limited, and generally mild to moderate in the NGX-4010 group and less frequent and severe in the controls.

INTERPRETATION

One 60-min application of NGX-4010 provided rapid and sustained pain relief in patients with postherpetic neuralgia. No adverse events were associated with treatment except for local reactions at the site of application and those related to treatment-associated pain.

Authors+Show Affiliations

University of Wisconsin-Madison, Madison, WI 53792, USA. backonja@neurology.wisc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18977178

Citation

Backonja, Miroslav, et al. "NGX-4010, a High-concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia: a Randomised, Double-blind Study." The Lancet. Neurology, vol. 7, no. 12, 2008, pp. 1106-12.
Backonja M, Wallace MS, Blonsky ER, et al. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol. 2008;7(12):1106-12.
Backonja, M., Wallace, M. S., Blonsky, E. R., Cutler, B. J., Malan, P., Rauck, R., & Tobias, J. (2008). NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. The Lancet. Neurology, 7(12), 1106-12. https://doi.org/10.1016/S1474-4422(08)70228-X
Backonja M, et al. NGX-4010, a High-concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia: a Randomised, Double-blind Study. Lancet Neurol. 2008;7(12):1106-12. PubMed PMID: 18977178.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. AU - Backonja,Miroslav, AU - Wallace,Mark S, AU - Blonsky,E Richard, AU - Cutler,Barry J, AU - Malan,Philip,Jr AU - Rauck,Richard, AU - Tobias,Jeffrey, AU - ,, Y1 - 2008/10/30/ PY - 2008/11/4/pubmed PY - 2009/1/24/medline PY - 2008/11/4/entrez SP - 1106 EP - 12 JF - The Lancet. Neurology JO - Lancet Neurol VL - 7 IS - 12 N2 - BACKGROUND: The limitations of current treatments for postherpetic neuralgia (PHN) have led to the investigation of localised, non-systemic alternatives. NGX-4010, a high-concentration (8%) capsaicin dermal patch, was developed to treat patients with neuropathic pain. We report the results of a randomised, double blind, 12-week study of the efficacy and safety of one application of NGX-4010 in patients with PHN. METHODS: In this multicentre, double-blind, parallel-group trial, 402 patients were randomly assigned to one 60-min application of NGX-4010 (640 microg/cm(2) [8% capsaicin]) or a low-concentration capsaicin control patch (3.2 microg/cm(2) [0.04% capsaicin]). Patients were aged 18-90 years, had had postherpetic neuralgia for at least 6 months, and had an average baseline numeric pain rating scale (NPRS) score of 3 to 9. The primary efficacy endpoint was percentage change in NPRS score from baseline to weeks two to eight. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00115310. FINDINGS: Patients who were randomly assigned to NGX-4010 (n=206) had a significantly greater reduction in pain during weeks two to eight than did patients who had the control patch (n=196). The mean changes in NPRS score were -29.6%vs -19.9% (difference -9.7%, 95% CI -15.47 to -3.95; p=0.001). 87 (42%) patients who received NGX-4010 and 63 (32%) controls had a 30% or greater reduction in mean NPRS score (odds ratio [OR] 1.56, 95% CI 1.03 to 2.37; p=0.03). The patients who had NGX-4010 had significant improvements in pain during weeks two to 12 (mean change in NPRS score -29.9%vs -20.4%, difference -9.5, -15.39 to -3.61; p=0.002). Transient blood pressure changes associated with changes in pain level were recorded on the day of treatment, and short-lasting erythema and pain at the site of application were common, self-limited, and generally mild to moderate in the NGX-4010 group and less frequent and severe in the controls. INTERPRETATION: One 60-min application of NGX-4010 provided rapid and sustained pain relief in patients with postherpetic neuralgia. No adverse events were associated with treatment except for local reactions at the site of application and those related to treatment-associated pain. SN - 1474-4422 UR - https://www.unboundmedicine.com/medline/citation/18977178/NGX_4010_a_high_concentration_capsaicin_patch_for_the_treatment_of_postherpetic_neuralgia:_a_randomised_double_blind_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1474-4422(08)70228-X DB - PRIME DP - Unbound Medicine ER -