FDA issued a draft guidance
to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF), while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug.
This is just one of the steps FDA recently outlined in an action plan
to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.
Related: FDA requires warning on opioids
“For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care,” said FDA Commissioner Robert Califf, MD. “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. But, strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy.”
FDA is encouraging industry efforts to develop pain medicines 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, FDA has not approved an opioid product with properties that are expected to deter abuse if the product is swallowed whole,” FDA said in a statement.
Related: FDA makes sweeping changes for opioids
To better understand the real-world impact of ADF therapies and continue to support innovation in this space, FDA has required 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 the ADFs are not failsafe and more data are needed, ADF opioids do have properties expected to deter abuse compared to non-ADFs,” FDA said. “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The draft guidance, “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products
”, 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.
To encourage additional input from outside experts and the public, the agency will also hold a public meeting later this year to discuss the draft guidance on generic ADF products and a broad range of issues related to the use of abuse-deterrent technology as one tool to reduce prescription opioid abuse. FDA will take this feedback into consideration when developing the final guidance on this topic.
“Collaboration is critical in fostering innovation in the field of abuse deterrence,” said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “It is essential that a generic product is no less abuse-deterrent than the brand name product. We look forward to actively engaging in discussions to help inform our thinking about the evaluation of abuse-deterrent technologies.”
FDA is encouraging all stakeholders to comment on the draft guidance
through the 60-day comment period.
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