Posted 13 June 2017
By Michael Mezher
The US Food and Drug Administration (FDA) on Tuesday announced its next move in addressing the ongoing opioid abuse epidemic will be to take a closer look at the data supporting abuse-deterrent labeling for opioids.
At a two-day public workshop in July, FDA will meet with experts to look at how the agency can better evaluate the impact that abuse-deterrent opioids have on the growing epidemic.
"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," said FDA Commissioner Scott Gottlieb.
To date, FDA has approved ten opioids with abuse-deterrent properties—such as being difficult to crush or dissolve—including OxyContin (oxycodone hydrochloride), MorphaBond (morphine sulfate) and RoxyBond (oxycodone hydrochloride).
But while FDA has continued to encourage the development of abuse-deterrent opioids, some experts have questioned the limitations of such drugs, noting that in many cases the abuse-deterrent properties can be bypassed.
FDA has required postmarketing studies for all opioids with abuse-deterrent claims, but now the agency is looking for input on how best to use that data to measure the impact of these products, as well as ways to generate new data or improve study designs to better inform its regulatory decisions.
Alongside the workshop announcement, FDA also released a 20-page "Issues Paper" that discusses the currently available data sources and statistical considerations for evaluating the impact of abuse-deterrent opioids.
According to FDA, studying safety outcomes related to prescription drug abuse is particularly challenging, as many of the events occur outside the health care system and must be looked at across a wide-variety of data sources, including Poison Control Center call data, addiction treatment programs, as well as drug diversion and web monitoring programs.
Opioid Epidemic and FDA's Latest Actions
According to the US Centers for Disease Control and Prevention (CDC), more than 183,000 people in the US died from prescription opioid overdoses between 1999 and 2015, and in 2015 alone, roughly half of the 33,000 deaths related to opioids involved a prescription product.
In his first month as FDA Commissioner, Gottlieb called the opioid abuse epidemic FDA's "greatest immediate challenge," and set up an Opioid Policy Steering Committee at the agency.
Last week, FDA asked Endo Pharmaceuticals to pull Opana ER (oxymorphone hydrochloride) from the market after determining its benefits no longer outweigh its risks. According to the agency, this was the first time it has asked a company to withdraw an actively marketed opioid.
FDA said it made the decision in light of a "significant shift in the route of abuse of Opana ER from nasal to injection following the product's reformulation." FDA also noted that in 2012 it declined Endo's bid to add abuse-deterrent labeling to a reformulated version the drug, saying that while the reformulation met the agency's standards for approval, Endo did not demonstrate that it could "meaningfully reduce abuse."
In 2013, FDA withdrew Perdue Pharma's new drug application (NDA) for its original formulation for OxyContin for safety reasons after abuse-deterrent labeling was added to a new formulation of the drug. But, Purdue had already stopped marketing the original formulation in 2010, so FDA's action served mainly to prevent generic versions of the original formulation from entering the market.
FDA, Workshop Announcement, Issues Paper