The US Food and Drug Administration (FDA) issued guidelines to manufacturing industry which will help manufacturers develop abuse-deterrent opioid drugs.
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. Opioid drugs is benefecial for patients if used properly. Opioid drugs are commonly prescribed to relieve pain. There are several different types, including oxycodone, hydrocodone, morphine, and codeine. Prescription opioid products are an important component of modern pain management. However, a buse and misuse of these products have created a serious and growing public health problem. The FDA is working with drug manufacturers to combat opioid misuse and abuse. FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and 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 is working with many drug makers to support advancements in this area and help drug makers navigate the regulatory path to market as quickly as possible. In working with industry, the FDA will take a flexible, adaptive approach to the evaluation and labeling of potentially abuse-deterrent products. FDA is also working in many other ways to help prescribers and patients make the best possible choices about how to use these powerful drugs.
As part of its announcement, the FDA issued a document called, “Guidance for Industry: Abuse-Deterrent Opioids — Evaluation and Labeling,” in which it outlined how future studies can determine if a new drug has abuse-deterrent properties. The FDA also outlined how each study can be evaluated and discussed in terms of label claims.
This guidance also does not address issues associated with the development or testing of generic formulations of abuse-deterrent opioid products. FDA intends to address that topic in one or more future guidance documents. FDA organized a public meeting in October 30-31, 2014, to discuss about manufacturing and regulation of abuse-deterrent formulations of opioid medications.
“Development of abuse-deterrent products is a priority for the FDA, and we hope this guidance will lead to more approved drugs with meaningful abuse-deterrent properties,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.