Press Pulse

The FDA's Support For Abuse-Deterrent Opioids May Not Be Enough

CJ Arlotta
29 March 2016

The U.S. Food and Drug Administration (FDA) last week publicly released a draft guidance on the agency’s outlook on supporting the development of generic versions of approved opioids with abuse-deterrent formulations (ADFs), with the intention of also ensuring that these formulations are no less abuse-deterrent than the brand name drug.

The 34-page document, titled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products,” also includes recommendations on how additional research to demonstrate this comparison should be conducted. The federal agency designed its plan to focus on policies aimed at reversing the country’s opioid epidemic, while also addressing treatment availability for patients in pain.

There were 18,893 deaths involving prescription opioids in the United States in 2014, up 16% from 2013, according to the National Center for Health Statistics (NCHS).

The FDA outlines the abuse deterrence of generic solid oral opioid drug products, general principles for evaluating the abuse deterrence of generic solid oral opioid drug products, routes of abuse, in vitro studies and other considerations.

“For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care,” FDA Commissioner Robert Califf said in a statement. “We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy.”

Even with abuse-deterrent properties, which attempt to prevent users from crushing or dissolving the drug, opioids can still be abused by patients if they’re swallowed whole. The FDA has not approved any opioid product with properties that are expected to deter abuse if the product is ingested entirely by the user.

Via email, Andrew Kolodny, chief medical officer at Phoenix House, a drug treatment facility, said the FDA’s proposed guidance doesn’t provide appropriate labeling rules for ADFs.

“For starters, the FDA shouldn’t be allowing these drugs to be labeled as ‘abuse-deterrent’ because they don’t really deter abuse–they deter misuse by specific routes. If a pill has been made difficult to crush, it should be labeled ‘crush resistant,’” he said, “or if it has a drug added to it to deter injection use, it should be labeled ‘injection-resistant.’ One of the main problems with calling them ‘abuse deterrent’ is that the terms ‘abuse’ and ‘addiction’ are often used interchangeably”…