Paul D Gavin1, Louise Tremper1, Alisha Smith1, Gemma Williams2, Charles Brooker3. 1. Phosphagenics Limited, 11 Duerdin Street, Clayton VIC 3168, Australia. 2. Health Writers S.L., Velazquez, 59 28001 Madrid, Spain. 3. MJC Pain Management Research Centre, Royal North Shore Hospital, St Leonards, NSW 2065, Australia.
Abstract
AIM: 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. RESULTS: 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. CONCLUSION: 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.
RCT Entities:
AIM: 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. RESULTS: 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. CONCLUSION: 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.
Authors: Giulia Di Stefano; Andrea Di Lionardo; Giuseppe Di Pietro; Giorgio Cruccu; Andrea Truini Journal: Pain Res Manag Date: 2021-04-26 Impact factor: 3.037
Authors: Cherkaouia Kibaly; Jacob A Alderete; Steven H Liu; Hazem S Nasef; Ping-Yee Law; Christopher J Evans; Catherine M Cahill Journal: Cell Mol Neurobiol Date: 2020-11-27 Impact factor: 4.231