The FDA has issued draft guidance intended to support the pharma industry in its development of generic versions of approved opioids with abuse-deterrent formulations (ADFs) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug. The new guidance is among a number of steps the agency recently outlined in an action plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the current opioid-abuse epidemic, while still providing patients in pain access to effective relief.
“We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse,” said FDA Commissioner Robert Califf, MD. “But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy.”
In the draft guidance, the agency encourages industry efforts to develop pain medications that are more difficult to abuse. Abuse-deterrent properties make certain types of abuse, such as crushing a tablet in order to snort the contents or dissolving a capsule in order to inject its contents, more difficult or less rewarding. It does not mean the product is impossible to abuse or that these properties necessarily prevent addiction, overdose, or death. Notably, the FDA has not approved an opioid product with properties that are expected to deter abuse if the product is swallowed whole.
To better understand the real-world impact of ADF therapies and to continue to support innovation in this space, the FDA is requiring all sponsors of brand-name products with approved abuse-deterrent labeling to conduct long-term epidemiological studies to assess their effectiveness in reducing abuse in practice. While the FDA recognizes that ADFs are not failsafe and that more data are needed, ADF opioids do have properties expected to deter abuse compared with non-ADFs.
“Given the lower cost, on average, of generic products, encouraging access to generic forms of ADF opioids is an important step toward balancing the need to reduce opioid abuse with helping to ensure access to appropriate treatment for patients in pain,” the FDA said in its announcement.
The draft guidance includes recommendations about the studies that should be conducted to demonstrate that a generic opioid is no less abuse-deterrent than the brand-name product with respect to all potential routes of abuse.