Postmarketing Research for Opioid Abuse-Deterrent Formulations: A Narrative Review

Area of Science:

• Pharmacology
• Public Health
• Drug Development

Background:

• Prescription opioid analgesics face restricted availability due to concerns about abuse and misuse.
• Opioid abuse-deterrent formulations (ADFs) were developed to resist tampering while maintaining analgesic efficacy.
• The US Food and Drug Administration (FDA) categorizes ADF approval based on preclinical, pharmacokinetic, and clinical evidence.

Purpose of the Study:

• To review the benefits and necessity of ADFs in pain management.
• To outline FDA guidance for ADFs, emphasizing postmarketing evaluation (Category 4).
• To summarize postmarketing studies of currently available US ADF prescription opioids.

Main Methods:

• Conducted a narrative review of existing literature on opioid ADFs.
• Identified key postmarketing publications through PubMed searches and citation tracking.
• Focused on four ADFs: XTAMPZA ER, OXYCONTIN, HYSINGLA ER, and ROXYBOND.

Main Results:

• Three ADFs (XTAMPZA ER, OXYCONTIN, HYSINGLA ER) have reported postmarketing research.
• These studies generally indicate reduced nonoral abuse or misuse compared to non-ADFs or other ADFs.
• XTAMPZA ER demonstrated sustained lower nonoral abuse/misuse levels despite increased prescriptions.

Conclusions:

• The overall impact of ADFs on abuse, misuse, and clinical outcomes requires further investigation.
• None of the current ADFs have achieved Category 4 FDA labeling based on postmarketing studies.
• Additional postmarketing research is particularly needed for HYSINGLA ER and ROXYBOND.