Sex and race analysis of pharmacokinetics of crush-resistant oxymorphone extended release 40 mg under fasted conditions

Abstract

Sex and race have been associated with differences in the metabolism of some opioid formulations. An oxymorphone extended release (ER) formulation designed to be crush-resistant was found to be bioequivalent to traditional oxymorphone ER.1 This post hoc analysis of the bioequivalence study assessed sex and race differences in crush-resistant oxymorphone ER pharmacokinetics. Institutional review board approval was received, and 37 healthy adults were enrolled with written informed consent. Subjects received 2 single doses of crush-resistant oxymorphone ER 40 mg and traditional oxymorphone ER 40 mg under fasted conditions.