FDA Reveals New Guidance for Abuse-Deterrent Opioid Development

Food and Drug Administration (FDA) has issued final guidance for manufacturers on the development and labeling of abuse-deterrent opioids, the agency announced last week. The guidance document, “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling,” recommends the studies manufacturers should conduct to show that a given drug formulation is abuse-deterrent. The guidance also suggests labeling claims that FDA might approve based on those studies. Abuse-deterrent drugs would still be effective when taken as prescribed, but would be difficult to crush, inject, or snort. The agency encourages the development of abuse-deterrent drugs and notes that “While drugs with abuse-deterrent properties are not ‘abuse-proof,’ the FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse.” FDA is currently working on similar guidance for generic opioids.