That’s been the main reason that none of the 10 “abuse-deterrent” opioids approved by FDA to date have labeling that the drugs reduce abuse — they are only “expected” to do so.
Indeed, one such product, Opana ER, was just removed from the market because it led to an increase in injection abuse, which was tied to an outbreak of HIV and hepatitis C in Indiana, as well as cases of thrombotic thrombocytopenic purpura (TTP) across the country.
The new formulation of Opana was harder to crush, which made it more difficult to snort, but those determined to abuse it found a way to cook it down and inject it instead.
Opana ER was never officially given any abuse-deterrent labeling by FDA, but the company went to great lengths to paint it as an abuse-deterrent formulation.
Other drugmakers have also stumbled in this realm: In 2015, Purdue Pharma nixed a supplemental New Drug Application related to the ability of abuse-deterrent OxyContin to diminish abuse in the real world. It did so just 1 day before the agency was going to release its evaluation of the application.
To avoid similar problems with other abuse-deterrent formulations, the FDA invited a wide range of experts with diverse perspectives — from expertise in drug abuse and addiction treatment to those who have conducted surveillance on other public health problems — to the hearing.
While the first day focused on improving the use of existing data sources, such as poison control center data, population-based surveys, and claims data, day 2 focused on developing and using new data sources, including building on established national surveys, and designing studies that assess exposure and outcomes in the same individuals over time.
Staffa said the path forward will likely involve a “mosaic” approach that incorporates data from multiple imperfect sources.
During several public comment periods, industry representatives noted that many insurers are refusing to cover the drugs because they haven’t been shown to reduce abuse in the real world. That, in turn, is driving down the number of patients on abuse-deterrent formulations, which isn’t making it any easier to study outcomes, they argued.
Staffa noted that abuse-deterrent opioid prescriptions have fallen from 5.6 million in 2011 — the year after the first formulation was approved — to 4.3 million in 2016.
The FDA said it’s accepting comments on means of assessing real-world outcomes with abuse-deterrent drugs through Sept. 11, 2017.
FDA Commissioner Scott Gottlieb, MD, opened the first day of the meeting by announcing that the FDA will now include immediate-release opioids in its risk evaluation and mitigation strategy (REMS) for opioids. Previously, the REMS had focused on extended-release and long-acting products, but Gottlieb noted that 90% of the 200 million opioid prescriptions written each year in the U.S. are for these fast-acting products.
The education that comes with the REMS program, however, will continue to be voluntary, not mandatory. It will be expanded to include modules for nurses, pharmacists, and other practitioners who prescribe opioids, Gottlieb said.
The agency is also still considering whether to make education mandatory, he added.
An updated draft blueprint for that education expands the amount of information focused on pain management, including non-pharmacologic treatment for pain and non-opioid alternatives, and on opioid use disorders.
The agency is also initiating a study to better understand exactly how prescribers perceive the term “abuse-deterrent” and whether their perceptions “match clinical realities.”
