The U.S. Food and Drug Administration today issued a
draft guidance document to assist industry in developing new
formulations of opioid drugs with abuse-deterrent properties.
The document “Guidance for Industry: Abuse-Deterrent
Opioids – Evaluation and Labeling,” explains the
FDA’s current thinking about the studies that should be
conducted to demonstrate that a given formulation has
abuse-deterrent properties, how those studies will be evaluated by
the agency, and what labeling claims may be approved based on the
results of those studies.
“The FDA is extremely concerned about the inappropriate
use of prescription opioids, which is a major public health
challenge for our nation,” said FDA Commissioner Margaret A.
Hamburg, M.D. “This draft guidance is an important part of a
larger effort by FDA aimed at preventing prescription drug abuse
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. 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. In working
with industry, the FDA will take a flexible, adaptive approach to
the evaluation and labeling of potentially abuse-deterrent
“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.”
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. At
the same time, the FDA remains committed to ensuring that patients
with pain have appropriate access to opioid analgesics.
This draft guidance fulfills mandates under the Food and Drug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.
“Our nation is in the midst of a prescription drug abuse
epidemic,” said Gil Kerlikowske, director of National Drug
Control Policy. “While there are no silver bullet solutions
to this public health and safety challenge, abuse-deterrent
formulations of powerful prescription opioids can make a difference
in addressing this epidemic. This guidance is a vitalcomponent of
the Administration’s comprehensive effort to reduce
prescription drug abuse in America, and we commend the FDA for its
commitment to this challenge.”
FDA is seeking public comment on the draft guidance for 60
days and encourages additional scientific and clinical research
that will advance the development and assessment of abuse-deterrent
technologies. Instructions on how to submit comments will be
announced in an upcoming Federal Register notice. The FDA will also
hold a public meeting to discuss and receive feedback on the draft
guidance. In finalizing the guidance document, the agency will
consider the information received from the public.
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation’s food supply, cosmetics, dietary supplements,
products that give off electronic radiation, and for regulating
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