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January 14, 2013

Draft guidance on studying and labeling abuse-deterrent opioids notice published in the Federal Register

By Jay Nawrocki, MA

The FDA is seeking comments on a draft guidance entitled "Abuse-Deterrent Opioids—Evaluation and Labeling" (Notice, 78 FR 2676, January 14, 2013). The draft guidance describes how to conduct studies and evaluations on abuse-deterrent properties of opioid analgesic products. The draft guidance also provides information that should be included in labeling of abuse-deterrent opioids. The FDA is seeking input on research topics listed in the final section of the draft guidance and is announcing that it will hold a public meeting on this issue as well. Comments are to be received by March 15, 2013, for inclusion in consideration of the final guidance. The draft guidance fulfills mandates under the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Office of National Drug Control Policy's (ONDCP) Prescription Drug Abuse Prevention Plan.

Abuse. The FDA considers development of these products, abuse-deterrent opioids, a high public health priority. Prescription opioids have been successful in the management of pain, but these products, however, have been subject to widespread abuse. These products have been abused in a variety of ways, including by swallowing them whole, crushing and then swallowing the product, crushing and then snorting the product, crushing and then smoking the product, dissolving the product, or injecting the product. Current abuse-deterrent technologies have not proven successful. "While prescription opioids are an important component of pain management, abuse and misuse of these products have resulted in too many injuries and deaths across the United States," said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research. "An important step towards the goal of creating safer opioids is the development of products that are specifically formulated to deter abuse."

Study designs. The draft guidance discusses how opioid pain killer should be studied specifically addressing (1) in vitro studies, (2) pharmacokinetic studies, (3) human abuse potential studies, and (4) post market studies. The laboratory based in vitro manipulation and extraction studies should examine how abusers may attempt to overcome the abuse deterrent properties. The studies should test simple and sophisticated methods of overcoming the abuse-deterrent strategies such as the ability and success of various devices like spoons, coffee grinders and cutters to crush the product as well as extractability and solubility studies to determine if the various components can be dissolved and extracted. The draft guidance discusses other abuse-deterrent mechanisms that could or should be tested.

Labeling and additional research. The draft guidance describes the types of information and claims that are to be included in the labeling information for abuse-deterrent opioid products. The FDA hopes that this guidance will result in a discussion amongst stakeholders concerning the appropriate development, evaluation, and labeling of these products. The FDA is also seeking input on several areas where additional scientific research and evaluation on the development of abuse deterrent strategies and devices would be helpful. It is the FDA's intent that the guidance when finalized will provide a clear framework for the evaluation and labeling of abuse-deterrent opioids.

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