Abuse-deterrent opioids: an update on current approaches and considerations

Abstract

Objective: Abuse and misuse of prescription opioids is a significant public health concern. This review examines the strategies used to confer abuse-deterrent properties on opioid abuse-deterrent formulations (ADFs), the characteristics and supporting data for each of the available ADFs, and the role of opioid ADFs as part of a comprehensive opioid risk management plan.

Methods: A PubMed search was performed for articles published within the last 10 years using the search terms “abuse deterrent opioids”. Articles were limited to clinical studies and reviews focusing on United States (US) Food and Drug Administration (FDA)-approved opioid ADFs in the US.

Results: There are currently nine extended-release and one immediate-release opioid pain medications with US FDA-approved ADF labelling. All use either physical and chemical barriers or agonist/antagonist combinations to deter manipulation and abuse. Evidence is mounting that introduction of opioid ADFs has been associated with decreased rates of abuse and diversion of opioids in the US.

Conclusions: Although not sufficient by themselves to prevent prescription opioid abuse and misuse, opioid ADFs are an important component of a healthcare provider’s comprehensive opioid risk management plan (along with utilization of prescription drug monitoring programs, clinical assessment tools, urine tests, co-prescribing of naloxone to patients at risk of an overdose, access to non-pharmacological treatments and addiction/mental health resources, among others). Adoption of opioid ADFs should be considered as part of an overall public health opioid risk management plan involving all stakeholders to balance legitimate safe and effective use of opioids against misuse and abuse.

Keywords:

• Abuse
• Abuse-deterrent
• Misuse
• Opioids

Transparency

Declaration of funding

The medical writing and editorial support was funded by Daiichi Sankyo, Inc.

Declaration of financial/other relationships

J.V.P. has acted as a consultant/speaker and researcher for Baxter, BioDelivery Sciences International, Collegium, Daiichi Sankyo, Depomed, Endo, Grunenthal GmhB, Inspirion, Iroko, Mallinckrodt, Mundi Pharma, and Purdue Pharma. R.B.R. has acted as a consultant/advisor for AstraZeneca, Collegium, Daiichi Sankyo, Depomed, Egalet, Endo, Grunenthal, Inspirion, Iroko, Johnson & Johnson, Kaleo, KemPharm, Mallinckrodt/Covidien, Mundipharma, Neumentum, Pernix, Purdue Pharma, Shionogi, Teva, and Trevena. He is also a cofounder of CaRafe Drug Innovation and an investor with Chamounix Ventures. R.T. is an employee of NEMA Research. S.V. has acted as a consultant for Daiichi Sankyo, Depomed, Iroko, and Purdue Pharma. Daiichi had the opportunity to review the final manuscript draft, but manuscript content was solely at the discretion of the authors and reflects the opinions of the authors. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript, apart from those disclosed. One CMRO reviewer of the manuscript declared that they were affiliated with the RADARS System, which performs post-marketing surveillance of most opioid drugs including ADFs. All other peer reviewers have no relevant financial relationships to disclose.

Acknowledgments

Medical writing/editorial assistance was provided by Angela Cimmino, PharmD, and Kelly Cameron, PhD, ISMPP CMPP, of JB Ashtin, which was funded by Daiichi Sankyo, Inc.