Gavin Paul D, Tremper Louise, Smith Alisha, Williams Gemma, Brooker Charles
Phosphagenics Limited, 11 Duerdin Street, Clayton VIC 3168, Australia.
Health Writers S.L., Velazquez, 59 28001 Madrid, Spain.
Pain Manag. 2017 Jul;7(4):255-267. doi: 10.2217/pmt-2016-0067. Epub 2017 Apr 18.
To evaluate the efficacy, systemic exposure, safety and tolerability of a transdermal oxycodone patch containing tocopheryl phosphate mixture (TPM) in patients with postherpetic neuralgia (PHN).
PATIENTS & METHODS: The study was a Phase IIa, multicenter, randomized, double-blind, vehicle-controlled crossover study.
While the TPM/oxycodone patch did not significantly improve 'average' Numeric Pain Rating Scale scores versus vehicle patch, patients reporting high levels of paresthesia (n = 9) showed a trend toward improved pain reduction. The TPM/oxycodone patch resulted in a low systemic exposure to oxycodone and was well tolerated.
The TPM/oxycodone patch delivered oxycodone to the site of perceived pain in subjects suffering from PHN, but did not provide analgesia for the broad PHN indication.
评估含生育酚磷酸酯混合物(TPM)的透皮羟考酮贴剂在带状疱疹后神经痛(PHN)患者中的疗效、全身暴露量、安全性和耐受性。
该研究为IIa期、多中心、随机、双盲、赋形剂对照交叉研究。
虽然与赋形剂贴剂相比,TPM/羟考酮贴剂并未显著改善“平均”数字疼痛评分量表得分,但报告感觉异常程度较高的患者(n = 9)显示出疼痛减轻有所改善的趋势。TPM/羟考酮贴剂导致羟考酮的全身暴露量较低,且耐受性良好。
TPM/羟考酮贴剂可将羟考酮递送至PHN患者的疼痛感知部位,但未对广泛的PHN适应症提供镇痛作用。