NGX-4010, a Capsaicin 8% Dermal Patch, Administered Alone or in Combination With Systemic Neuropathic Pain Medications, Reduces Pain in Patients With Postherpetic Neuralgia.
Irving, Gordon A. MD *; Backonja, Miroslav MD +; Rauck, Richard MD ++; Webster, Lynn R. MD [S]; Tobias, Jeffrey K. MD [//]; Vanhove, Geertrui F. MD, PhD [//]
[Article]
Clinical Journal of Pain.
28(2):101-107, February 2012.
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Objectives: Analyses of integrated data from 4 controlled postherpetic neuralgia studies evaluated the effect of NGX-4010, a capsaicin 8% patch, administered alone or together with systemic neuropathic pain medications.
Methods: Patients recorded their "average pain for the past 24 hours" daily for 12 weeks using an 11-point Numeric Pain Rating Scale (NPRS). Efficacy assessment included the percentage NPRS score reduction from baseline during weeks 2 to 8 and 2 to 12, the proportion of patients responding during weeks 2 to 8 and 2 to 12 and the Patient Global Impression of Change (PGIC) at weeks 8 and 12.
Results: During the studies, 302 NGX-4010 and 250 control (capsaicin, 0.04% wt/wt) patients were using at least 1 systemic neuropathic pain medication; 295 NGX-4010 and 280 control patients were not. During weeks 2 to 8, NGX-4010 patients reported greater reductions in NPRS scores compared with control both in patients using systemic neuropathic pain medications (-26.1% vs. -18.1%, P=0.0011) and in patients not using these medications (-36.5% vs. -26.2%, P=0.0002). Patients not using systemic neuropathic pain medications reported a greater reduction in pain compared with patients using these medications in both, NGX-4010 and control groups, resulting in comparable treatment differences between NGX-4010 and control regardless of systemic neuropathic pain medication use. Similar results were seen during weeks 2 to 12, for the responder and PGIC analyses. Transient, capsaicin-related application site reactions were the most common adverse events and not affected by systemic neuropathic pain medication use.
Conclusion: A single 60-minute NGX-4010 treatment reduces PHN for up to 12 weeks regardless of concomitant systemic neuropathic pain medication use.
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