Prescription opioids are powerful pain-reducing medications that include prescription oxycodone, hydrocodone and morphine, among others, and have both benefits as well as potentially serious risks. These medications can help manage pain when prescribed for the right condition and when used properly. But when misused or abused, they can cause serious harm, including addiction, overdose and death.
Recently, too many citizens have been impacted by the serious harms associated with these medications. In response to the current opioid crisis facing our country, FDA has developed a comprehensive action plan to take concrete steps toward reducing the impact of opioid misuse and abuse. For the latest information on FDA actions related to opioid medications please see the sections and links below.
- In response to the current opioid crisis the FDA has established a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan focuses on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.
- To help combat the opioid epidemic, the FDA is also encouraging efforts to make it harder or less rewarding to abuse opioids. On March 24, 2016 FDA issued a draft guidance titled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products .” This guidance recommends studies a generic applicant should conduct so FDA can evaluate the abuse deterrence of certain generic opioid drug products and help ensure that generic versions of approved opioids with abuse-deterrent formulations (ADFs) are no less abuse-deterrent than the brand named drug.
- Opioid medications have the potential to provide significant pain-relieving benefit for patients when used as directed for their approved indications; however, opioids also carry serious risks of misuse, abuse, neonatal opioid withdrawal syndrome (NOWS), addiction, overdose, and death. FDA has been actively working to find ways to mitigate these serious risks associated with the use of opioids, while continuing to ensure that patients in pain have appropriate access to these products.
- There are two primary categories of opioid medications: immediate release (IR) , which are the most often prescribed type of opioid, and extended-release /long-acting (ER/LA). The labeling for both have recently received multiple updates to more effectively communicate to prescribers the serious risks associated with these drugs.
- FDA has approved a number of drug products that address opioid addiction or overdose. Methadone and buprenorphine products are part of the class of extended-release and long-acting (ER/LA) opioids and are approved for the treatment of opioid addiction. This type of treatment is often referred to as medication-assisted treatment (MAT). Regarding overdose, in November 2015 the FDA approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. Also, in April 2014, the FDA approved a prescription naloxone hydrochloride injection, which can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. This formulation rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet.
- Annually approximately 100 million people in the United States suffer from pain and 9 million to 12 million of them have chronic or persistent pain, while the remainder have short-term pain from injuries, illnesses, or medical procedures. All of patients in pain should benefit from skillful and appropriate pain management, which may include the judicious use of opioid medicines in conjunction with other methods of treatment or in circumstances in which nonaddictive therapies are insufficient to control pain. Clearly, though, more research on pain control is warranted. The FDA applauds the work done by the U.S. Department of Health and Human Services and the entire Interagency Pain Research Coordinating Committee to further efforts to encourage more research and awareness of the management of chronic pain. We are also working with NIDA to encourage the development of nonaddictive pain medications.
The FDA is encouraging the development of abuse-deterrent opioid formulations to help combat the opioid epidemic. The agency recognizes that abuse-deterrent opioids are not abuse-proof but are a step toward products that will help reduce abuse. The FDA fully supports efforts to better understand the impact of these products in the real-world setting and develop innovative formulations that have the potential to make abuse of these products more difficult or less rewarding. This does not mean a product is impossible to abuse or that abuse-deterrent properties necessarily prevent overdose and death. Notably, currently marketed technologies do not effectively deter one of the most common forms of opioid abuse -- swallowing the tablet or capsule. Because opioid medications must in the end be able to deliver the opioid to the patient, there may always be some potential for addiction and abuse of these products.
What does abuse-deterrent really mean?
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. 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 helping drug makers navigate the regulatory path to market as quickly as possible. In working with industry, the FDA is taking a flexible, adaptive approach to the evaluation and labeling of potentially abuse-deterrent products.
Opioids with FDA-Approved Labeling Describing Abuse-Deterrent Properties
FDA has approved these extended-release/long-acting (ER/LA) opioids with labeling describing abuse-deterrent properties consistent with the FDA’s Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling:
There are currently NO immediate-release or generic opioids with FDA-approved abuse-deterrent labeling.
How does the FDA decide what drugs are considered abuse-deterrent?
To meet the FDA’s standards, it is essential that every opioid with labeling describing its abuse-deterrent properties be grounded in science and supported by evidence. Any claims regarding abuse-deterrent properties must be truthful and not misleading based on a product’s labeling, and supported by sound science taking into consideration the totality of the data for the particular drug. Absent sufficient science, there can be no claim of abuse deterrence. Permitting insufficiently proven claims does not serve the public health.
The FDA has issued two guidances to help industry understand how the agency currently is evaluating these innovative products.
- “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” (final guidance) explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. It also makes recommendations about how those studies should be performed and evaluated, and discusses what labeling claims may be approved based on the results of those studies.
- “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products” (draft guidance) includes recommendations about the studies that should be conducted to demonstrate that a generic opioid is no less abuse-deterrent than the brand name product, with respect to all potential routes of abuse.
How will abuse-deterrent opioids help with the epidemic?
Because abuse-deterrent products are expected to reduce abuse compared to non-abuse-deterrent products, the agency is very interested in encouraging and supporting abuse-deterrent opioid formulations as part of the FDA’s Opioid Action Plan. The FDA looks forward to a future in which most or all opioid medications are available in formulations that are less susceptible to abuse than the formulations that are on the market today. To achieve this goal, FDA is taking steps to incentivize and support the development of opioid medications with progressively better abuse-deterrent properties. These steps include working with individual sponsors on promising abuse-deterrent technologies; developing appropriate testing methodologies for both innovator and generic products; and publishing guidance on the development and labeling of abuse-deterrent opioids.
We continue to encourage the development of innovative abuse-deterrent technologies, and we are also prioritizing the need for data that will help determine the impact of products incorporating abuse-deterrent technology on misuse and abuse. To collect this important information, all of the companies that have brand name opioids with abuse-deterrent labeling claims are being required to conduct post-market studies to determine the impact those products are having in the real world. Having that information is critical and will allow us to take the next important steps in this area.
- In February 2016, FDA leadership authored a Special Report published in the New England Journal of Medicine, which put forth a broad range of immediate and specific actions to help address opioid abuse. In this report FDA committed to: reassessing the risk/benefit analysis FDA applies to opioid drug product approvals, gaining expert input from Advisory Boards and the Scientific Board at FDA, reviewing label and postmarket requirements, prioritizing abuse-deterrent formulations and overdose treatments and supporting a range of research efforts in areas such as pain management in children and the development of non-opioid alternatives for pain management.
- Currently, Extended-Release and Long-Acting (ER/LA) Opioids are subject to Risk Evaluation and Mitigation Strategy (REMS) program. A REMS program may be required by the FDA as part of the approval of a new product, or for an approved product when new safety information arises. Essentially, a REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use. On May 3 and 4, 2016, FDA Advisory Committees will discuss results from assessments of the ER/LA Opioid Analgesics REMS.
- The FDA has compiled a timeline to provide chronological information about agency activities and significant events related to opioids. Included on this page is a summary timeline of key events, followed by tabbed years that provide selected additional actions and more detail about the items listed in the summary.
FDA Issues Draft Guidance on Abuse-Deterrent Formulations of Generic Opioids New Safety Measures Announced for Immediate Release (IR) Opioids New Safety Measures Announced for Extended-release and Long-acting Opioids Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids FDA Statement in Support of the 2013 National Drug Control Strategy
Safe Disposal of Medicines
- The New England Journal of Medicine Special Report: A Proactive Response to Prescription Opioid Abuse