Real-world impact of abuse-deterrent formulation of XTAMPZA ER in the context of behaviors around tampering with XTAMPZA® ER and other opioid products

Real-world impact of abuse-deterrent formulation of XTAMPZA ER in the context of behaviors around tampering with XTAMPZA® ER and other opioid products

Background:

Abuse-deterrent formulations (ADFs) of opioids were developed to discourage tampering and have been shown to dissuade some persons who use opioids from transitioning from oral to non-oral use (1). ADFs are used for all extended-release (ER) oxycodone drugs, but limited information exists on their impact in real-world settings (2). Additionally, little is known about individuals’ motivations behind tampering, perceptions around effectiveness of tampering, and understanding of risks associated with the manipulation of ADF opioids.

Purpose/Objectives:

This study compares the rate of tampering with XTAMPZA® ER to the rate of tampering with immediate-release (IR) single entity (SE) oxycodone, other ER oxycodone opioids, and ER oxymorphone in order to assess the efficacy of ADF technology in a real-world setting. Additionally, this study explores behaviors associated with non-medical use (NMU) of this product in the general population to better understand tampering methods, reasons for tampering, and reported success of tampering with this and comparator products.

Method:

Cross-sectional data from two Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) System data sources were utilized. Serial cross-sectional data from the Treatment Center Programs Combined was collected upon entry into opioid use disorder (OUD) treatment center programs. Repeated cross-sectional survey data from the Survey of Non-Medical Use of Prescription Drugs (NMURx) Program was utilized. NMURx respondents who reported NMU of XTAMPZA® ER, other ER ADF opioids, non-ADF ER oxycodone/hydrocodone products, or IR SE oxycodone were included. This analysis investigated the odds of tampering between XTAMPZA® ER and comparators in a treatment center population using logistic regression. Demographic and behavioral information about tampering was obtained via the NMURx Program, and descriptive percentages were provided.

Results:

Data from 2,273 participants was collected from entrants to treatment centers and from 628 general population participants. The odds of tampering for XTAMPZA® ER were significantly lower than those of immediate-release single-entity oxycodone (OR=0.23, p-value=0.0002) and ER oxymorphone (OR=0.30, p-value=0.0038), but not significantly different from those of other ER ADF oxycodone products (OR=0.50, p-value=0.0612). Of those who reported NMU in the general population, the lowest proportion reported NMU of XTAMPZA® ER compared to other products, although these respondents exhibited higher proportions of risky behaviors and negative outcomes.

Conclusions: Tampering with XTAMPZA® ER was reported less frequently than most comparator products in an OUD treatment center population, and NMU of this product was reported less frequently than other products in the general population. These findings highlight the impact of ADF technology in discouraging non-oral use among individuals with OUD. As such, there is a need for more research into the uptake of ADF opioids and identification of related barriers. There is also a need to better understand the relatively small group of individuals who successfully tamper with XTAMPZA® ER. Though the number of general population participants who NMU this product was comparatively low, a higher percentage of tampering was observed for this group, which may indicate that these individuals are more experienced with manipulation. This study highlights the need to compare the efficacy of many different ADF technologies across multiple data sets.

References: 1. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, Abuse-Deterrent Opioids—Evaluation and Labeling: Guidance for Industry. 2015, Department of Health and Human Services: Silver Springs: MD.
2. Larance, B., et al., The effect of potentially tamper-resistant oxycodone formulation on opioid use and harm: main findings of the National Opioids Medications Abuse Deterrence (NOMAD) study. The Lancet Psychiatry, 2018. 5(2): p. 155-166.