A Randomized, Crossover Study on the Effect of Food on the Pharmacokinetic Characteristics of Morphine ARER (MorphaBond™ ER), an Abuse-Deterrent Formulation of Extended-Release Morphine

Food alters how the body processes some currently available opioids. How the opioid is formulated in the final commercial product can impact this effect. Morphine ARER is a new oral abuse-deterrent formulation of extended-release morphine created with properties to make it more difficult to abuse via the intranasal and intravenous routes. To better understand how food affects Morphine ARER bioavailability, we compared the amount of morphine in the blood when 100 mg of Morphine ARER was given with or without food, in random order, to 27 healthy volunteers. Plasma samples were collected up to 48 h after dosing to measure the concentrations of morphine and its active metabolite morphine-6-glucuronide. We measured the amount of drug absorbed by using the area under the plasma concentration-time curve (AUC) and the rate of drug absorption by looking at the highest amount of drug observed in the blood using the maximum observed plasma concentration (Cmax) and time to Cmax (Tmax). When subjects were fed, the Cmax for morphine was 33% higher (44.78 ng/ml) than when they fasted (33.30 ng/ml). The median Tmax was 30 min longer when subjects were fed. Total morphine exposure (AUC0–∞) was similar when subjects were fed (440.6 ng · h/ml) or when they fasted (395.1 ng · h/ml). Safety was evaluated throughout the treatment periods by adverse events, either observed by the clinician or reported by subjects. The most common adverse events noted were somnolence (e.g., sleepiness) and nausea. Our findings show that Morphine ARER has similar bioavailability when taken with or without food.