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NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomized, double-blind, controlled study with an open-label extension.
Pain Med. 2010 Apr; 11(4):600-8.PM

Abstract

OBJECTIVES

To assess the efficacy, tolerability, and safety of NGX-4010, a high-concentration capsaicin dermal patch (capsaicin 640 microg/cm(2), 8%) in patients with postherpetic neuralgia (PHN).

METHODS

Patients were randomized to receive NGX-4010 or control patch in a 4-week, double-blind study. This was followed by an open-label extension phase (up to 48 weeks total) where patients could receive up to three additional treatments no sooner than 12 weeks after initial treatment. The primary efficacy variable was mean change from baseline in mean morning and evening numerical pain rating scale (NPRS) scores.

RESULTS

During days 8-28 after the double-blind treatment, NGX-4010 patients had a mean change in NPRS scores from baseline of -32.7% compared with -4.4% for control patients (P = 0.003). Mean NPRS scores decreased from baseline during week 1 in both treatment groups, remained relatively stable through week 12 in NXG-4010 patients, but returned to near baseline during weeks 2-4 in controls. Mean change in NPRS scores from baseline during weeks 2-12 was -33.8% for NGX-4010 and +4.9% for control recipients. A similar decrease in NPRS scores from baseline was maintained with subsequent NGX-4010 treatments, regardless of the number of treatments received. Transient increases in application site pain were adequately managed with analgesics. No increases in application site reactions or adverse events were observed with repeated treatments. No patients discontinued the study due to an adverse event.

CONCLUSION

NGX-4010 is a promising topical treatment for PHN patients, which appears to be tolerable, generally safe, and effective.

Authors+Show Affiliations

University of Wisconsin-Madison, Madison, Wisconsin, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

20113411

Citation

Backonja, Misha Miroslav, et al. "NGX-4010, a High-concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia: a Randomized, Double-blind, Controlled Study With an Open-label Extension." Pain Medicine (Malden, Mass.), vol. 11, no. 4, 2010, pp. 600-8.
Backonja MM, Malan TP, Vanhove GF, et al. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomized, double-blind, controlled study with an open-label extension. Pain Med. 2010;11(4):600-8.
Backonja, M. M., Malan, T. P., Vanhove, G. F., & Tobias, J. K. (2010). NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomized, double-blind, controlled study with an open-label extension. Pain Medicine (Malden, Mass.), 11(4), 600-8. https://doi.org/10.1111/j.1526-4637.2009.00793.x
Backonja MM, et al. NGX-4010, a High-concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia: a Randomized, Double-blind, Controlled Study With an Open-label Extension. Pain Med. 2010;11(4):600-8. PubMed PMID: 20113411.
* 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 randomized, double-blind, controlled study with an open-label extension. AU - Backonja,Misha Miroslav, AU - Malan,T Philip, AU - Vanhove,Geertrui F, AU - Tobias,Jeffrey K, AU - ,, Y1 - 2010/01/22/ PY - 2010/2/2/entrez PY - 2010/2/2/pubmed PY - 2010/8/24/medline SP - 600 EP - 8 JF - Pain medicine (Malden, Mass.) JO - Pain Med VL - 11 IS - 4 N2 - OBJECTIVES: To assess the efficacy, tolerability, and safety of NGX-4010, a high-concentration capsaicin dermal patch (capsaicin 640 microg/cm(2), 8%) in patients with postherpetic neuralgia (PHN). METHODS: Patients were randomized to receive NGX-4010 or control patch in a 4-week, double-blind study. This was followed by an open-label extension phase (up to 48 weeks total) where patients could receive up to three additional treatments no sooner than 12 weeks after initial treatment. The primary efficacy variable was mean change from baseline in mean morning and evening numerical pain rating scale (NPRS) scores. RESULTS: During days 8-28 after the double-blind treatment, NGX-4010 patients had a mean change in NPRS scores from baseline of -32.7% compared with -4.4% for control patients (P = 0.003). Mean NPRS scores decreased from baseline during week 1 in both treatment groups, remained relatively stable through week 12 in NXG-4010 patients, but returned to near baseline during weeks 2-4 in controls. Mean change in NPRS scores from baseline during weeks 2-12 was -33.8% for NGX-4010 and +4.9% for control recipients. A similar decrease in NPRS scores from baseline was maintained with subsequent NGX-4010 treatments, regardless of the number of treatments received. Transient increases in application site pain were adequately managed with analgesics. No increases in application site reactions or adverse events were observed with repeated treatments. No patients discontinued the study due to an adverse event. CONCLUSION: NGX-4010 is a promising topical treatment for PHN patients, which appears to be tolerable, generally safe, and effective. SN - 1526-4637 UR - https://www.unboundmedicine.com/medline/citation/20113411/NGX_4010_a_high_concentration_capsaicin_patch_for_the_treatment_of_postherpetic_neuralgia:_a_randomized_double_blind_controlled_study_with_an_open_label_extension_ L2 - https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/j.1526-4637.2009.00793.x DB - PRIME DP - Unbound Medicine ER -