Open AccessNGX‐4010, a High‐Concentration Capsaicin Patch, for the Treatment of Postherpetic Neuralgia: A Randomized, Double‐Blind, Controlled Study with an Open‐Label Extension
Author(s) -
Backonja Misha Miroslav,
Malan T. Philip,
Vanhove Geertrui F.,
Tobias Jeffrey K.
Publication year - 2010
Publication title -
pain medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.893
H-Index - 97
eISSN - 1526-4637
pISSN - 1526-2375
DOI - 10.1111/j.1526-4637.2009.00793.x
Subject(s) - postherpetic neuralgia , medicine , tolerability , morning , adverse effect , evening , capsaicin , anesthesia , randomized controlled trial , neuralgia , double blind , neuropathic pain , physics , receptor , alternative medicine , pathology , astronomy , placebo
Objectives. To assess the efficacy, tolerability, and safety of NGX‐4010, a high‐concentration capsaicin dermal patch (capsaicin 640 μg/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.