The U.S. Food and Drug Administration will further assess whether the abuse-deterrent properties of certain opioid medications are helping to mitigate the rising rates of opioid addiction, according to an agency statement made Tuesday by FDA Commissioner Scott Gottlieb, MD.
Here are five things to know.
1. Opioids designed to deter abuse are equipped with features that either make them difficult to crush or dissolve, or are manufactured to limit the euphoric high a user feels when snorting or injecting the drugs.
2. While Dr. Gottlieb said abuse-deterrent formulations are an important area of focus for the FDA, he acknowledged little data exist as to the drugs' real-world influence on the opioid epidemic.
"Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof. These drugs can still be abused, particularly orally, and their use can still lead to new addiction," Dr. Gottlieb said. "Nonetheless, these new formulations may hold promise as one part of a broad effort to reduce the rates of misuse and abuse. One thing is clear: we need better scientific information to understand how to optimize our assessment of abuse-deterrent formulations."
3. The FDA will host a public meeting July 10-11 where the agency will "engage external thought leaders in a discussion about how we can better leverage existing data sources and methods to evaluate the impact of these products in the real world, as well as what new data sources and study designs could be developed or enhanced to ensure these efforts result in the best possible answers to inform regulatory decision-making," according to Dr. Gottlieb's statement.
4. The intensified scrutiny on abuse-deterrent opioids comes as the regulatory agency looks to make the nation's opioid crisis a priority under the leadership of Dr. Gottlieb. On June 8, the FDA pressured drugmaker Endo International to remove its opioid painkiller Opana ER from the market. The move marked the first time in history the agency pushed a drugmaker to withdraw an opioid from the market for public health concerns.
5. In 2010, Purdue Pharma released a version of the blockbuster opioid OxyContin that was difficult to crush, which became the first to receive "abuse-deterrent" designation. Since the drug's introduction to the marketplace, heroin overdoses in the U.S. have increased dramatically. Previous research has suggested OxyContin reformulation is responsible for as much as 80 percent of the recent surge in heroin overdose deaths.
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