(236) A harm reduction model to quantify potential misuse/abuse reduction and misuse/abuse-related events avoided from extended-release abuse deterrent opioids

Abstract

Misuse/abuse of prescription opioids has been recognized as a public health crisis by the U.S. FDA and the FDA’s Opioid Action Plan recognizes abuse-deterrent (AD) formulation of opioids as critical to mitigating opioid misuse/abuse. Morphine AD, extended-release injection-molded tablets (ADER-IMT) have been demonstrated to resist common and rigorous forms of physical and chemical manipulation and reduce drug liking compared with non-AD morphine extended-release (ER). We used a harm reduction model-based approach to investigate the extent of the potential to reduce opioid misuse/abuse-related events by simulating, over 5 years, the replacement of all non-AD morphine ER formulations with morphine-ADER-IMT. Model input prevalence was based on privately-insured administrative claims database analyses, substance abuse treatment center and poison control center data, and national surveys. Estimated reductions in non-medical use (NMU) with morphine-ADER-IMT were derived from a combination of in-vitro manipulation assessment data and subjective measures of abuse potential from clinical studies comparing morphine-ADER-IMT with non-AD morphine ER. Different assumptions about market share capture by morphine-ADER-IMT result in a range of possible harm reduction scenarios that can be presented. The assumption applied herein is illustrative of complete market capture by morphine-ADER-IMT from generic ER morphine over 5 years: 20% generic and 20% branded market share capture in year 1, with 20% growth each year to 100% over 5 years. This scenario results in a 22% reduction in substance abuse treatment and predicts 246,448; 64,855; and 38,913 avoided outpatient, emergency department visits and hospitalizations, over 5 years, respectively. For injection-related complications (ie., HIV/AIDs, hepatitis, endocarditis, cellulitis, and phlebitis), it is estimated that 12,644 events would be avoided. This scenario is estimated to prevent 329 deaths over 5 years. This modelling analysis suggests that replacement of non-AD morphine ER with morphine-ADER-IMT could lead to significant reductions in opioid abuse-related outcomes. Funded by Egalet Corporation.