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• W2116714845 abstract "Current therapies for postherpetic neuralgia (PHN) frequently provide incomplete pain relief and their use is often limited by side effects. NGX-4010 is a high-concentration capsaicin dermal patch (capsaicin, 8%) being evaluated as a treatment for PHN. We conducted an integrated analysis using data from 4 controlled PHN studies with 597 patients receiving a single 60-minute treatment with NGX-4010 and 530 control (low-concentration capsaicin patch [0.04% w/w]) patients. Throughout a 12-week controlled study period, patients recorded their “average pain for the past 24 hours” daily using an 11-point Numeric Pain Rating Scale (NPRS). The primary efficacy assessment was the percentage change in NPRS score from Baseline during Weeks 2 to 8. Patient Global Impression of Change (PGIC) was assessed at Weeks 4, 8, and 12. There were no meaningful differences in baseline pain characteristics between the 2 groups across the 4 studies. The mean percentage change in NPRS score from Baseline was significantly greater with NGX-4010 than control during both Weeks 2 to 8 (−31.2% vs −22.3%; p < 0.0001) and 2 to 12 (−31.3% vs −22.6%; p < 0.0001). A greater proportion of NGX-4010 patients achieved a ≥ 30% response compared with control patients during Weeks 2 to 8 (43.6% vs 33.6%; p = 0.0004) and 2 to 12 (44.9% vs 35.3%; p = 0.0006). PGIC results significantly differed at Weeks 8 and 12 (p < 0.0001 for both) with more NGX-4010–treated patients reporting being very much/much improved compared to controls (Week 8, 37.3% vs 24.8%; Week 12, 36.5% vs 23.7%, respectively). NGX-4010 was generally well tolerated; 98% of patients completed the prescribed application time. Transient application site reactions including erythema and pain were the most common adverse events. These data support the conclusion that NGX-4010 has the potential to provide an effective, nonsystemic treatment option for patients with PHN. (Study supported by a grant from NeurogesX, Inc.)" @default.
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• W2116714845 date "2009-04-01" @default.
• W2116714845 modified "2023-10-01" @default.
• W2116714845 title "Integrated analysis of efficacy and safety of NGX-4010, a high-concentration capsaicin patch, in patients with postherpetic neuralgia" @default.
• W2116714845 doi "https://doi.org/10.1016/j.jpain.2009.01.178" @default.
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