FDA issues guidance on development of abuse-deterrent opioid formulations

January 10, 2013

FDA issued a draft guidance on Jan. 9 to help industry in the development of opioid drug formulations with abuse-deterrent properties, saying it considers development of these products a high public health priority.

FDA issued a draft guidance on Jan. 9 to help industry in the development of opioid drug formulations with abuse-deterrent properties, saying it considers development of these products a high public health priority.

The agency says the guidance provides recommendations for “the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated, and what labeling claims may be approved based on the results of those studies.”

The announcement pointed to several possible deterrents to abuse including physical barriers to prevent chewing, crushing, cutting, grating, or grinding; chemical barriers that resist the extraction of the opioid using common solvents; agonist/antagonist combinations in which the antagonist would be active if the product is crushed or injected, for example; and aversion to create an unpleasant effect if the drug is manipulated prior to injection or a dose higher than directed is used.

In a telephone call with reporters, Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, was repeatedly asked why drug manufacturers would be motivated to develop abuse-deterrent products if generic products don’t use the same standard.

Dr. Throckmorton said FDA has received citizen petitions on the generic issue and will address them. However, he said, the hope is that if a product is labeled as having abuse-deterrent properties, that will make it more attractive for physicians to prescribe because it is safer.

He also said that the science of abuse deterrence is evolving and there are a number of things not well understood. If there are other mechanisms to achieve abuse deterrence, the agency would be interested in hearing about them, he asserted.

FDA is asking for comments on the guidance within the next 60 days, and it will announce a meeting on the issue in the future.