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A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia.
Pain Med. 2011 Jan; 12(1):99-109.PM

Abstract

OBJECTIVES

To confirm the efficacy, tolerability, and safety of NGX-4010, an 8% capsaicin dermal patch (capsaicin 640 µg/cm(2)), in patients with postherpetic neuralgia (PHN). PHN is a chronic pain disorder that can be difficult to treat and for which current treatment options are often limited by poor tolerability.

DESIGN

A total of 418 patients were randomized to receive a single 60-minute application of NGX-4010 or a 0.04% capsaicin control patch (3.2 µg/cm(2)) in a multicenter, double-blind, confirmatory, phase 3 study.

PATIENTS

Patients were 18-90 years old with a diagnosis of PHN, pain for at least 6 months, and an average baseline Numeric Pain Rating Scale (NPRS) score of 3-9.

OUTCOME MEASURES

The primary efficacy end point was the percentage change in NPRS score from baseline to weeks 2-8.

RESULTS

NGX-4010 recipients had a significantly greater mean reduction from baseline in pain during weeks 2-8 compared with the control group (32.0% vs 24.4%; P=0.011). A ≥ 30% reduction in mean NPRS scores was achieved in 46% of NGX-4010 recipients compared with 34% of controls (P=0.02). Pain was significantly lower in NGX-4010 recipients than controls by week 2, and greater pain reduction was maintained throughout the remaining 12-week study period. Most treatment-emergent adverse events were application site specific (notably erythema and pain), transient, and generally mild to moderate in severity.

CONCLUSIONS

In patients with PHN, a single 60-minute application of NGX-4010 produced significant reduction in pain that was maintained over a 12-week period.

Authors+Show Affiliations

Swedish Pain Center, Seattle, Washington, USA.No 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

21087403

Citation

Irving, Gordon A., et al. "A Multicenter, Randomized, Double-blind, Controlled Study of NGX-4010, a High-concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia." Pain Medicine (Malden, Mass.), vol. 12, no. 1, 2011, pp. 99-109.
Irving GA, Backonja MM, Dunteman E, et al. A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. Pain Med. 2011;12(1):99-109.
Irving, G. A., Backonja, M. M., Dunteman, E., Blonsky, E. R., Vanhove, G. F., Lu, S. P., & Tobias, J. (2011). A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. Pain Medicine (Malden, Mass.), 12(1), 99-109. https://doi.org/10.1111/j.1526-4637.2010.01004.x
Irving GA, et al. A Multicenter, Randomized, Double-blind, Controlled Study of NGX-4010, a High-concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia. Pain Med. 2011;12(1):99-109. PubMed PMID: 21087403.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. AU - Irving,Gordon A, AU - Backonja,Miroslav M, AU - Dunteman,Edwin, AU - Blonsky,E Richard, AU - Vanhove,Geertrui F, AU - Lu,Shiao-Ping, AU - Tobias,Jeffrey, AU - ,, Y1 - 2010/11/18/ PY - 2010/11/20/entrez PY - 2010/11/23/pubmed PY - 2011/5/5/medline SP - 99 EP - 109 JF - Pain medicine (Malden, Mass.) JO - Pain Med VL - 12 IS - 1 N2 - OBJECTIVES: To confirm the efficacy, tolerability, and safety of NGX-4010, an 8% capsaicin dermal patch (capsaicin 640 µg/cm(2)), in patients with postherpetic neuralgia (PHN). PHN is a chronic pain disorder that can be difficult to treat and for which current treatment options are often limited by poor tolerability. DESIGN: A total of 418 patients were randomized to receive a single 60-minute application of NGX-4010 or a 0.04% capsaicin control patch (3.2 µg/cm(2)) in a multicenter, double-blind, confirmatory, phase 3 study. PATIENTS: Patients were 18-90 years old with a diagnosis of PHN, pain for at least 6 months, and an average baseline Numeric Pain Rating Scale (NPRS) score of 3-9. OUTCOME MEASURES: The primary efficacy end point was the percentage change in NPRS score from baseline to weeks 2-8. RESULTS: NGX-4010 recipients had a significantly greater mean reduction from baseline in pain during weeks 2-8 compared with the control group (32.0% vs 24.4%; P=0.011). A ≥ 30% reduction in mean NPRS scores was achieved in 46% of NGX-4010 recipients compared with 34% of controls (P=0.02). Pain was significantly lower in NGX-4010 recipients than controls by week 2, and greater pain reduction was maintained throughout the remaining 12-week study period. Most treatment-emergent adverse events were application site specific (notably erythema and pain), transient, and generally mild to moderate in severity. CONCLUSIONS: In patients with PHN, a single 60-minute application of NGX-4010 produced significant reduction in pain that was maintained over a 12-week period. SN - 1526-4637 UR - https://www.unboundmedicine.com/medline/citation/21087403/A_multicenter_randomized_double_blind_controlled_study_of_NGX_4010_a_high_concentration_capsaicin_patch_for_the_treatment_of_postherpetic_neuralgia_ L2 - https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/j.1526-4637.2010.01004.x DB - PRIME DP - Unbound Medicine ER -