薬理と治療

Abstract

Background and Objectives　Conventional topical non-steroidal anti-inflammatory drugs are intended to exert local action. In contrast, HP-3150 was developed as a novel, once-daily, systemically-acting, transdermal diclofenac formulation. We conducted an open-label, uncontrolled, long-term study to evaluate the safety and efficacy of HP-3150 administration. Methods　Two HP-3150 patches（150 mg diclofenac sodium）were administered to each patient with low back pain once daily for 52weeks. Data regarding adverse events（AEs）, clinical laboratory tests, and visual analogue scale（VAS）scores were collected. Results　Most of the AEs occurring in 135 patients treated with the investigational product were mild in severity, indicating no major safety concerns. Kidney and liver function test parameters were almost unchanged from baseline to the final assessment. The mean （±standard deviation）change in VAS score from baseline（43.7±20.4 mm）to the final assessment was-23.7±24.9 mm. These results demonstrate the efficacy of HP-3150 when administered repeatedly for 52 weeks. Conclusions　A 52-week treatment with HP-3150 was well tolerated, had no major safety concerns, and provided a long-term stable pain control. （JPRN-Japic CTI-205103）