Intranasal administration of crushed ALO-02 (extended-release oxycodone with sequestered naltrexone): A randomized, controlled abuse-potential study in nondependent recreational opioid users

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