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Pain Manag. 2017 Nov;7(6):499-512. doi: 10.2217/pmt-2017-0032. Epub 2017 Aug 17.

A Phase I study of the pharmacokinetics, safety and tolerability of a novel tocopheryl phosphate mixture/oxymorphone transdermal patch system.

Author information

1
Phosphagenics Limited, Unit A8, 2A Westall Road, 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
Linear Clinical Research Ltd, QEII Medical Center, Nedlands, WA 6009, Australia.

Abstract

AIM:

Characterize the pharmacokinetic profile and tolerability of two tocopheryl phosphate mixture/oxymorphone patch formulations in healthy subjects, and the active metabolite (6-OH-oxymorphone).

MATERIALS & METHODS:

Fifteen participants received a single application of oxymorphone patches +/- capsaicin for 72 h and were crossed-over for another 72 h.

RESULTS:

Plasma oxymorphone was detected approximately 7 h and 6-OH-oxymorphone after approximately 18-19 h postapplication of both formulations, respectively. For oxymorphone, median tmax was 24 h, and Cmax/Cmin ratio was approximately 2.4. The most frequently reported treatment-related adverse event was application site reaction, mainly with capsaicin formulation.

CONCLUSION:

Tocopheryl phosphate mixture/oxymorphone transdermal patches can successfully deliver therapeutic amounts of oxymorphone in a sustained manner over 72 h and are well tolerated. ANZCTR registration number: ACTRN12614000613606.

KEYWORDS:

oxymorphone; tocopheryl phosphate mixture (TPM); transdermal patch

PMID:
28814158
DOI:
10.2217/pmt-2017-0032
[Indexed for MEDLINE]

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