FDA offers guidance on the evaluation and labelling of abuse-deterrent painkillers


Regulator hopes to encourage industry to develop formulations that are more difficult to crush, snort or inject

The US Food and Drug Administration has issued guidance to help the pharma industry develop new opioid drugs that could help prevent drug abuse.

The regulator said in its document, Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labelling, that it hopes to encourage manufacturers to develop painkiller formulations that are more difficult to crush, snort or inject to produce a more intense high, but acknowledges that drugs with abuse-deterrent properties are not 'abuse-proof'.

Properties to deter abuse could include physical/chemical barriers; agonist/antagonist combinations; aversion; delivery system, including use of depot injectable formulations and implants; new molecular entities and prodrugs; and novel approaches of technologies not covered by the previous categories, the FDA said.

The FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with reducing their misuse and abuse.

The science of abuse-deterrent medication is rapidly evolving

The document explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. It also makes recommendations about how those studies should be performed and evaluated, and discusses what labelling claims may be approved based on the results of those studies.

'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,' said FDA Commissioner Margaret Hamburg.

'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.'

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While this guidance does not address generic opioid products, the FDA said it understands the importance of making generic options available to ensure appropriate access to effective painkillers for patients who need them. It said it is committed to support the development and use of generic drugs that have abuse-deterrent properties and is working on draft guidance in this area.