Abuse-deterrent (AD) formulations of opioids have been deemed an important component of risk mitigation for opioid abuse. A novel morphine AD extended-release (ER), injection-molded tablet (ADER-IMT) product candidate has been developed using proprietary Guardian™ technology (Egalet Corporation, Wayne, PA) utilizing an injection molding manufacturing process that produces hard tablets that are resistant to rigorous physical and chemical manipulations. The bioequivalence of morphine ADER-IMT and a marketed non-AD morphine ER product were assessed in two phase 1, randomized, open-label, single-dose, crossover studies in healthy adults aged 18–55 years. In study 1 (n=66), fasted subjects received oral morphine ADER-IMT (30 mg), morphine ER (30 mg), or morphine ADER-IMT (2 × 15 mg) in 3 sequential periods. In study 2, one cohort (n=40) received morphine ADER-IMT (60 mg) or morphine ER (60 mg) under fasting conditions in 2 treatment periods; a second cohort (n=25) received morphine ADER-IMT (60 mg) under fed conditions in an additional treatment period. In both studies, all subjects received naltrexone 50 mg before and after each study drug administration. Pharmacokinetic parameters for morphine included area under the plasma concentration vs time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-t), AUC from time 0 extrapolated to infinity (AUC0-inf), and maximum plasma concentration (Cmax). Bioequivalence criteria were from Food and Drug Administration guidelines. In study 1, (fasting conditions) bioequivalence was demonstrated among all 3 treatments (morphine ADER-IMT [30 mg], morphine ER [30 mg], and morphine ADER-IMT [2 × 15 mg]) for all 3 pharmacokinetic parameters. In study 2, bioequivalence (fasting conditions) was demonstrated between morphine ADER-IMT (60 mg) and morphine ER (60 mg); further, the fed/fasted analysis demonstrated no clinically relevant food effect for morphine ADER-IMT (60 mg). Morphine ADER-IMT was generally well tolerated with no unexpected adverse events. Funded by Egalet Corporation.