P-091 - Curbing Opioid Abuse: Real-World Evidence of Abuse-Deterrent Formulations

Abstract Title: Curbing Opioid Abuse: Real-World Evidence of Abuse-Deterrent Formulations

Background: For patients who experience refractory chronic pain, opioid analgesics remain an important component of multimodal treatment; however, opioid misuse and abuse pose a serious and challenging public health problem.¹ Prescription opioids were associated with approximately 45 deaths per day in 2021, totaling more than 17,000 deaths.² Opioid abuse-deterrent formulations (ADFs) were developed as a component of a multifactorial strategy to combat the opioid epidemic.^3-4 To date, there are 4 opioids (1 immediate release [IR] and 3 extended release [ER]) with US Food and Drug Administration (FDA)—approved abuse-deterrence label claims, including ROXYBOND^TM IR (oxycodone), reformulated OXYCONTIN ER® (oxycodone), HYSINGLA ER® (hydrocodone), and XTAMPZA ER® (oxycodone). XTAMPZA ER utilizes an ADF technology called DETERx, while HYSINGLA ER and OXYCONTIN ER use RESISTEC^®and ROXYBOND uses SentryBond^TM to deter abuse and misuse.^4,5 In a recent study utilizing clinical outcome data from the National Poison Data System and healthcare cost data from the Healthcare Cost and Utilization Project, intentional misuse/abuse exposures to XTAMPZA ER resulted in significantly fewer emergency department admissions and lower hospital costs than other IR or ER oxycodone products.⁶

Purpose/Objectives: To present the real-world evidence (RWE) assessing the relative risk of XTAMPZA ER, a drug employing ADF technology, compared with non-ADF prescription analgesics.


Methods: Real-world evidence delivers important information on the relative risk of abuse of currently available opioid medications. The Addiction Severity Index-Multimedia Version (ASI-MV) is RWE that was used to determine the rates of nonmedical use and nonoral-nonmedical use of non-ADF and ADF opioids.⁷ Data from the treatment centers programs combined, which are included in the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) system, were used to compare tampering rates of XTAMPZA ER with non-ADF opioids.⁸ RADARS system data sources were also used to compare the postmarketing rates of misuse, abuse, and diversion of XTAMPZA ER with other prescription opioid analgesics.⁹


Results: XTAMPZA ER had significantly lower rates of nonmedical use including nonoral nonmedical use than OXYCONTIN (P< 0.001) and the non-ADF oxycodone IR (P< 0.001) products in individuals seeking substance abuse treatment.⁷ XTAMPZA ER had significantly lower odds of tampering compared with non-ADF oxycodone IR (P< 0.001) and ER oxymorphone (P=0.004) in a treatment-center population.⁸ A study evaluating the RADARS system found low rates of abuse, misuse, and diversion of XTAMPZA ER compared with other prescription opioid analgesics; abuse and diversion did not increase over the study period.⁹

Conclusions/Implications for future research and/or clinical care: Together, these RWE studies indicate that in persons who are known to misuse opioids, XTAMPZA ER, a drug employing ADF technology, has lower rates of abuse, misuse, and diversion and reduces the likelihood of tampering when compared with non-ADF prescription analgesics.


References: 1. US Food and Drug Administration. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products guidance for industry. Center for Drug Evaluation and Research; Rockville, MD. 2017.

2. Centers for Disease Control and Prevention. Opioid data analysis and resources. Accessed February 2, 2024. https://www.cdc.gov/opioids/data/analysis-resources.html.

3. Kopecky EA, Fleming AB, Levy-Cooperman N, et al. J Clin Pharmacol. 2017;57(4):500-512.

4. Adler JA, Mallick-Searle T. J Multidiscip Healthc. 2018;11:323-332.

5. Cone EJ, Giordano J, Weingarten B. Drug Alcohol Depend. 2013;131(1-2):100-105.

6. Green JL, Dailey-Govoni T, Vosburg SK. Healthcare costs associated with rates of prescription opioid misuse/abuse. Presented at: Pain Week Conference 2023; September 5-8, 2023; Las Vegas, NV.

7. Green JL, Robbins RS, Dailey-Govoni T, et al. J Pain Res. 2021;14:1773-1783.

8. Jewell J, Black J, Ellis M, et al. Clin Drug Investig. 2023;43(3):197-203.

9. Severtson GS, Kreider SED, Amioka EC, et al. Pain Med. 2020;21(12):3660-3668.