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FDA Takes Aim at Abuse-Deterrent Opioids
New FDA Commissioner Scott Gottlieb, MD, says the agency wants to know whether abuse-deterrent prescription opioids “are having their intended impact on limiting abuse and helping to curb the epidemic.”
To help get a meaningful answer, Gottlieb has called a public meeting for July 10 and 11, 2017, to “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.”
The meeting will seek to find or create “new data sources and study designs to ensure the best possible answers” about abuse-deterrent formulations which will influence regulatory decision-making.
Abuse- deterrent prescription opioids are designed to “deter” abuse by various methods, such as snorting or injecting. Some formulations make crushing a pill to dissolve it in a liquid for injection or into a powder for snorting more difficult. Others combine naloxone with the main active ingredient to block the “high” of the opioid.
“This has been an important area of innovation that the FDA continues to support,” Gottlieb said. “However, we recognize that there is a gap in our understanding of whether these products result in a real-world, meaningful decrease in the frequency and patterns of opioid misuse and abuse.”
For anyone interested in attending the public meeting or learning more about the issues involved, the agency has made available for download an issues paper outlining existing regulatory and public health challenges.
As we reported two weeks ago, the new Commissioner told his first staff meeting that “our greatest immediate challenge is the problem of opioid abuse.” This was followed by the news a week later that the FDA has asked for an abuse-deterrent prescription painkiller, Opana ER, to be taken off the market because it’s been so widely abused.
“Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof,” Gottlieb said in a lengthy statement about expanding the FDA’s role in combating the opioid epidemic. “These drugs can still be abused, particularly orally, and their use can still lead to new addiction.”
However, the Commissioner said, these new formulations “may hold promise” as part of a broad effort to reduce abuse.
“We recognize there is a gap in our understanding of whether these products result in a real world, meaningful decrease in the frequency and patterns of opioid misuse and abuse,” he said. “One thing is clear: We need better scientific information to understand how to optimize our assessment of abuse deterrent formulations.”
In his statement, Gottlieb said that “everyone at the FDA is committed to focusing on all aspects of the epidemic.” As part of this program, a steering committee is being formed to examine “additional regulatory and policy actions to combat this crisis” that can reduce the number of new cases of addiction.
The FDA has just published a paper, FDA Facts: Abuse-Deterrent Opioid Medications, that details the agency’s strong support for abuse deterrence formulations. It says that opioids with abuse-deterrent properties are, as Gottlieb says, “not abuse-proof.” But the agency points out that they are “a step toward products that will help reduce abuse.”
The agency “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,” the paper says. “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 is taking a flexible, adaptive approach to the evaluation and labeling of potentially AD products.”
Here’s a list of the currently approved brand-name abuse-deterrent prescription opioids on the market. No generic versions have yet been approved for abuse-deterrent labeling:
The FDA has approved the following opioids with labeling describing AD properties consistent with the FDA’s Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling:
- OxyContin – oxycodone, Purdue Pharma
- Targiniq ER – oxycodone and naloxone, Purdue Pharma
- Embeda – morphine and naltrexone, Pfizer Inc.
- Hysingla ER – hydrocodone, Purdue Pharma
- MorphaBond – morphine, Daiichi Sankyo, Inc.
- Xtampza ER – oxycodone, Collegium Pharmaceutical Inc
- Troxyca ER – oxycodone and naltrexone, Pfizer Inc.
- Arymo ER – morphine, Egalet Corp.
- Vantrela ER – hydrocodone, Teva Pharm.
- RoxyBond – oxycodone, Inspirion
We can certainly see the popularity of oxycodone – half of the 10 approved formulations are built around that drug. Three are morphine and two are hydrocodone. Three are designed with the antagonists naloxone or naltrexone, the rest with some sort of crush and dissolve resistance.
It does look like the FDA is working hard to be responsive to the opioid epidemic. Meanwhile we are working hard to help those that want to end their dependency on opioids.
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