Intranasal Administration of Crushed ALO-02 (Extended-Release Oxycodone With Sequestered Naltrexone): A Randomized, Controlled Abuse-Potential Study in Nondependent Recreational Opioid Users

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Abstract

ALO-02 is an abuse-deterrent formulation consisting of capsules filled with pellets of extended-release oxycodone surrounding sequestered naltrexone. This randomized, double-blind, placebo-/active-controlled, 4-way crossover study examined the abuse potential of crushed ALO-02 administered intranasally to healthy, nondependent, recreational opioid users. Following drug discrimination and naloxone challenge, eligible participants (n = 32) entered a 4-way crossover treatment phase: crushed single dose of 1 of 2 placebos, ALO-02 30 mg/3.6 mg (oxycodone/naltrexone) or oxycodone immediate-release (IR) 30 mg. Primary end points were Drug Liking and High, measured on visual analog scales (VAS) summarized as maximum effect (Emax) and effect occurring over 2 hours postdose (AUE0–2 h). Crushed ALO-02 resulted in significantly lower scores versus oxycodone IR on Drug Liking (Emax, 60.5 vs 92.8; AUE0–2 h, 105.4 vs 160.0, respectively) and High (Emax, 25.2 vs 86.9; AUE0–2 h, 27.1 vs 136.4, respectively; n = 28; P < .0001). Adverse events occurred most frequently with oxycodone IR, followed by ALO-02, then placebo, and were considered mild and consistent with opioid therapy. Crushed ALO-02 administered intranasally to nondependent recreational opioid users resulted in significantly lower scores on Drug Liking/High VAS and other positive subjective measures versus crushed oxycodone IR, suggesting less abuse potential. Demonstration of actual abuse deterrence in the real world requires further research.

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