Assessment of the safety and efficacy of extended-release oxycodone/acetaminophen, for 14 days postsurgery

Abstract

Objective:

To investigate the safety and satisfaction of patients treated ≤14 days after unilateral bunionectomy with extended-release oxycodone/acetaminophen (ER OC/APAP), a biphasic (ER and immediate release) fixed-dose combination analgesic being developed for moderate to severe acute pain.

Research design and methods:

This was an open-label extension (OLE) of a randomized, double-blind, placebo-controlled trial (DBRCT) of patients undergoing bunionectomy. Patients who consented to the OLE before entering the 48 hour DBRCT entered the OLE upon completing the DBRCT and during the OLE received two tablets of ER OC/APAP (15/650 mg total dose) every 12 hours for ≤14 days.

ClinicalTrials identifier:

ClinicalTrials.gov identifier: NCT01484652.

Main outcome measures:

Treatment-emergent adverse events, physical examinations, vital sign measurements, and clinical laboratory testing were assessed throughout the study. Global assessments of treatment satisfaction were made at the end of the DBRCT and at each clinic visit during the OLE.

Results:

A total of 146 patients consented to the OLE before entering the DBRCT and 129 completed the OLE. Tolerability of ER OC/APAP during the OLE was consistent with that of an opioid product. Adverse events occurred during the OLE in 64 patients (43.8%); the most common were gastrointestinal events including nausea (17.8%), vomiting (7.5%), and constipation (6.2%). No changes in vital signs or clinical laboratory tests were considered by the investigator to be clinically significant. At all visits during the OLE, the majority of patients were satisfied or very satisfied with their medication. Limitations include a 14 day postprocedure study duration that may be confounded with natural healing time, and lack of a placebo arm.

Conclusions:

These results show that ER OC/APAP demonstrated an expected safety and tolerability profile and good patient satisfaction in a postsurgical model of acute pain.

Keywords::

• Acetaminophen – Acute pain – Extended release – Oxycodone

Transparency

Declaration of funding

Funding for this research was provided by Mallinckrodt Pharmaceuticals, Hazelwood, MO, USA.

Declaration of financial/other relationships

N.S. has disclosed that he has received grants as a clinical investigator from Mallinckrodt. T.B., L.S., and J.Y. have disclosed that they are employees of Mallinckrodt. K.K. has disclosed that he is a paid consultant to Mallinckrodt.

CMRO peer reviewer 1 has no relevant financial or other relationships to disclose. CMRO peer reviewer 2 is a consultant to and on the Speakers’ Bureau of Mallinckrodt Pharmaceuticals.

Acknowledgments

Technical editorial and medical writing support for the development of this manuscript was provided by Michael Shaw PhD, Synchrony Medical Communications LLC (West Chester, PA, USA) and by Craig Albright PhD and Robert Gatley MD of C4 MedSolutions LLC, a CHC Group company (Yardley, PA, USA).

Previous presentation: Poster presented at PAINWeek 2013, 4–7 September 2013, Las Vegas, NV, USA.

Notes

*Xartemis (formerly known as MNK-795) is a registered trade name of Mallinckrodt Brand Pharmaceuticals Inc., Hazelwood, MO, USA