FDA encourages developing opioids with abuse-deterrent properties

To try and combat opioid-misuse and abuse, the FDA issued a final guidance today that will help industry in manufacturing products with possible drug-deterrent properties, according to a press release.

“Development of abuse-deterrent products is a priority for the FDA, and we hope this guidance will lead to more approved drugs with meaningful abuse-deterrent properties. While abuse-deterrent formulations do not make an opioid impossible to abuse and cannot wholly prevent overdose and death, they are an important part of the effort to reduce opioid misuse and abuse,” FDA Center for Drug Evaluation and Researcher Director, Janet Woodcock, MD, said in a press release.

The FDA acknowledged that while they recognize abuse-deterrent does not equal abuse-proof, they do believe this the first step in the right direction towards reducing opioid abuse and misuse.

Abuse-deterrent properties allow a drug to work when taken properly, but would make it difficult to abuse, due to formulation.

The guidance is pushing for studies that would be conducted to validate a drug’s abuse-deterrent properties, while also addressing how the studies should be performed and analyzed.

The FDA is working with drug makers to ensure that drugs that claim to have abuse-deterrent properties will be able to get the products on the market as quickly as possible.

While the guidance does not include information regarding generic opioid products, the FDA said that they are currently drafting an additional guidance for such drugs.

“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them. We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed,” FDA Commissioner Margaret A. Hamburg, MD, said in a press release.