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FDA Issues Draft Guidance On Abuse-Deterrent Opioids

 January 09, 2013 03:33 PM


(By Balaseshan) The U.S. Food and Drug Administration (FDA) issued a draft guidance on abuse-deterrent opioids in a move to prevent prescription drug abuse and misuse.

While prescription opioids are an important component of pain management, the health regulator said abuse and misuse of these products have resulted in too many injuries and deaths across the United States.

The FDA continues to encourage the development of abuse-deterrent formulations of opioids and believes that these products have promise to help reduce prescription drug abuse. 

The FDA considers the development of these products a "high" public health priority.

According to the FDA, opioids can be abused in a number of ways. Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance in that formulation.

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To date, the FDA said it has limited data correlating the potentially abuse-deterrent properties of certain opioid drug products with actual reduction in abuse or adverse events associated with abuse

The science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving, the FDA said.

This draft guidance fulfills mandates under the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Office of National Drug Control Policy's (ONDCP)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.

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The regulator said it is seeking comments on the draft guidance for 60 days from the public and encourages additional scientific and clinical research that will advance the development and assessment of abuse-deterrent technologies.

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