Transdermal Oxycodone Patch For The Treatment of Postherpetic Neuralgia: A Randomized, Double-Blind, Controlled Trial

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.

KEYWORDS:

• oxycodone
• postherpetic neuralgia
• transdermal patch

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: http://www.tandfonline.com/doi/full/10.2217/pmt-2016-0067

Acknowledgements

R Dworkin is thanked for his input to the experimental design and the interpretation of results.

Financial & competing interests disclosure

PD Gavin, L Tremper and A Smith are full-time employees of Phosphagenics Limited, Victoria, Australia. This study was funded by Phosphagenics Limited, Victoria, Australia. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The study was approved by an independent ethics committee and conducted in accordance with Good Clinical Practice (GCP; CPMP/ICH/135/95) and the Declaration of Helsinki. All subjects were included after having given their informed consent.

Additional information

Funding

PD Gavin, L Tremper and A Smith are full-time employees of Phosphagenics Limited, Victoria, Australia. This study was funded by Phosphagenics Limited, Victoria, Australia. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.