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Pain Manag. 2017 Jul;7(4):243-253. doi: 10.2217/pmt-2016-0068. Epub 2017 Apr 19.

Pharmacokinetics, safety and tolerability of a novel tocopheryl phosphate mixture/oxycodone transdermal patch system: a Phase I study.

Author information

1
Phosphagenics Limited, 11 Duerdin Street, Clayton VIC 3168, Australia.
2
SDG LLC, One Mifflin Place, Suite 400, Cambridge, MA 02138, USA.
3
Analgesia, Inc. Research, Austin, TX 78735, USA.
4
Royal Adelaide Hospital, University of Adelaide, Mail Delivery Point 22, North Terrace, 5000 Adelaide, Australia.

Abstract

AIM:

To characterize the pharmacokinetic profile and evaluate the safety and tolerability of a transdermal oxycodone patch containing tocopheryl phosphate mixture (TPM).

PATIENTS & METHODS:

Eleven healthy subjects received a single application of three TPM/oxycodone patches applied to the torso for 72 h.

RESULTS:

Oxycodone was detected 8.0 ± 2.7-h postpatch administration, reaching a mean maximum plasma concentration of 3.41 ± 1.34 ng/ml at 49.3 ± 21.2 h. The safety profile was consistent with the application method and known side-effect profile of oxycodone and naltrexone. No treatment-limiting skin irritation was observed.

CONCLUSION:

A 3-day application of the TPM/oxycodone patch demonstrated an acceptable safety profile and was well tolerated by healthy subjects, with limited dermal irritation following application.

KEYWORDS:

oxycodone; tocopheryl phosphate mixture (TPM); transdermal patch

PMID:
28421874
DOI:
10.2217/pmt-2016-0068
[Indexed for MEDLINE]

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