Differences in the severity of medical outcomes of exposures reported to poison centers involving XTAMPZA® ER and other opioid analgesics

The misuse of opioids in the United States for acute and chronic pain is a common occurrence and places individuals at a considerable risk for overdose and death. Abuse-deterrent formulations (ADFs) of opioids were developed and prioritized by the U.S. Food and Drug Administration (FDA) to reduce such harms associated with prescription opioid misuse and to discourage tampering. XTAMPZA® ER is an oxycodone analgesic with properties intended to discourage tampering. The impact of introducing ADFs on reduced harms in a community setting, outside of controlled trial conditions, is still being investigated.

Purpose/Objectives: The goal of this study was to assess exposures reported to poison centers associated with an ADF, XTAMPZA® ER, in a real world setting and compare to similarly indicated opioid analgesic drugs. We examined whether exposures to XTAMPZA ER® were less likely to be classified as intentional abuse/misuse/unknown or suspected suicidal compared to exposures involving other opioid analgesics. We also assessed whether exposures to XTAMPZA ER® resulted in less severe medical outcomes than exposures involving other opioid analgesics.

Method:

Data between 1^st quarter 2016 through 2^nd quarter 2022 from the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) System Poison Center Program were analyzed. The Poison Centers Program obtains data from 51 participating poison centers which manage exposure calls from individuals within the general population and from healthcare providers who are seeking advice regarding potential toxic exposures. Data from the Poison Centers program for cases involving 1) XTAMPZA^® ER, 2) immediate-release (IR) oxycodone 3) other ADF extended-release (ER) opioids, 4) other ER opioids 5) not otherwise specified (NOS) oxycodone, and 6) NOS morphine was analyzed for reason of exposure and medical outcome. The proportion of XTAMPZA^® ER exposures followed to a known medical outcome that were intentional were compared to other comparator opioid analgesics. Medical outcomes of XTAMPZA^® ER and other opioid analgesics were also compared for severity.

Results:

There were 189 XTAMPZA ER exposures that were followed to a known outcome, of which, 19 (10.05%) were intentional (abuse/misuse/unknown) and 60 (31.75%) were suspected suicidal. These percentages are statistically significantly less compared to other drug groups. All intentional exposures accounted for 2,815 (72.05%) cases reporting ADF extended-release (ER) opioids, 15,387 (77.78%) for not otherwise specified (NOS) oxycodone, 3,694 (61.45%) for immediate-release oxycodone, 3,569 (68.02%) for NOS morphine, and 1,190 (55.22%) for other ER opioids. XTAMPZA ER exposures resulted in lower percentages of major effect and death outcomes (14.3%) compared to other ADF ER opioids (17.2%) or NOS oxycodone (19.4%).

Conclusions: XTAMPZA® ER was involved in fewer intentional abuse/misuse/unknown exposures and exposures overall reported to poison centers compared to other opioid analgesics. Across all exposure groups, XTAMPZA® ER resulted in less severe medical outcomes, which may be explained by lower numbers of intentional exposures and the effect of its ADF properties. No unintended routes for XTAMPZA® ER were reported. Overall, these findings are consistent with reduced abuse related outcomes in the post marketing setting. Additional efforts, however, are still needed to reduce the burden of misuse and abuse of prescription opioids, which might include identification and treatment or mental health disorders and increased access to naloxone. Differences from other ADF opioids highlight the importance of evaluating the impact of ADF opioids in the real-world settings.

References: 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.

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.