The Comparative Pharmacokinetics of Physical Manipulation by Crushing of Xtampza^® ER Compared with OxyContin^®

Abstract

Aim: To further characterize the pharmacokinetics of Xtampza^® ER. Subjects & methods: This was an open-label, randomized, active-controlled, five-treatment, five-period, naltrexone-blocked, cross-over study. Healthy subjects received five equivalent oxycodone doses: Xtampza ER (intact or crushed), OxyContin^® (intact or crushed) or immediate-release (IR) oxycodone (crushed). Blood samples were collected to assess oxycodone concentrations. Results: Crushed and intact Xtampza ER resulted in lower peak plasma concentrations compared with crushed oxycodone IR; crushed and intact Xtampza ER were bioequivalent. Crushed OxyContin exhibited a rapid increase in plasma oxycodone and was bioequivalent to crushed oxycodone IR. Conclusion: This second pharmacokinetic study demonstrated that Xtampza ER maintains its ER properties after crushing, unlike OxyContin, which failed to retain its ER properties after crushing.

ANZCTR registration number: ACTRN12614000613606

KEYWORDS:

• abuse-deterrent
• extended-release
• oxycodone
• OxyContin^®
• pain
• prescription drug misuse
• Xtampza ER

Financial & competing interests disclosure

MJ Brennan has received grants/consultant fees/speakers’ bureaus fees from Purdue, Teva, Astra Zeneca, Pfizer, Depomed, Shionogi, Collegium, Iroko, Cara and Daiichi Sankyo. He is a stockholder of Cara. A Marseilles, M O’Connor and AB Fleming are full-time employees of Collegium Pharmaceutical, Inc., and hold stock and/or stock options. EA Kopecky was an employee of Collegium Pharmaceutical, Inc., at the time of the study; he is currently employed at TEVA Pharmaceutical Industries Ltd. This study was funded and supported by Collegium Pharmaceutical, Inc., Canton, MA, USA. 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.

Medical writing assistance, funded by Collegium Pharmaceutical, Inc., was provided by KM Cameron of JB Ashtin, who developed the first draft based on an author-approved outline and implemented author revisions. The authors thank Christy Thompson and Michael DeGeorge for their critical review of the manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have follwed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Additional information

Funding

MJ Brennan has received grants/consultant fees/speakers� bureaus fees from Purdue, Teva, Astra Zeneca, Pfizer, Depomed, Shionogi, Collegium, Iroko, Cara and Daiichi Sankyo. He is a stockholder of Cara. A Marseilles, M O�Connor and AB Fleming are full-time employees of Collegium Pharmaceutical, Inc., and hold stock and/or stock options. EA Kopecky was an employee of Collegium Pharmaceutical, Inc., at the time of the study; he is currently employed at TEVA Pharmaceutical Industries Ltd. This study was funded and supported by Collegium Pharmaceutical, Inc., Canton, MA, USA. 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. Medical writing assistance, funded by Collegium Pharmaceutical, Inc., was provided by KM Cameron of JB Ashtin, who developed the first draft based on an author-approved outline and implemented author revisions. The authors thank Christy Thompson and Michael DeGeorge for their critical review of the manuscript.