The FDA wants drugmakers to make cheaper, generic opioids that are harder to abuse. Experts question how much this will deter misuse of prescription opioids.
With the opioid epidemic in the United States showing no signs of letting up, the government has taken new steps to reduce the misuse of prescription opioids.
Last month, the U.S. Food and Drug Administration (FDA)
On the surface, this move seems like a reasonable step in addressing the opioid epidemic, which kills on average 91 Americans every day, according to the
But some experts say that pushing for wider adoption of harder-to-abuse prescription opioids — either generic or brand name — may not be the most effective way to reverse the epidemic.
To date, the FDA has approved 10 prescription opioids with
These are intended to make certain types of abuse more difficult or less rewarding, such as dissolving a capsule to inject the drug or crushing the tablet for snorting.
“The goal of ADFs is to maintain effective pain relief while reducing the potential for abuse,” said Joshua Cohen, PhD, an independent healthcare consultant and former research associate professor at Tufts Center for the Study of Drug Development (Tufts CSDD).
Several methods are used to make this happen.
For example, the abuse-deterrent version of OxyContin turns into a gel when dissolved, rather than a powder.
Other abuse-deterrent opioids release naloxone — an opioid antagonist that counteracts the effects of the opioid — when crushed.
Use of ADF opioids, though, are limited.
A report earlier this year from Tufts CSDD found that 96 percent of all opioid medications prescribed in the United States in 2015 lacked abuse-deterrent properties.
Part of the problem, said FDA Commissioner Dr. Scott Gottlieb in a
But an even bigger barrier to wider use of these drugs is price.
So far, all ADF opioids are available only as brand-name products.
For manufacturers, this is a good thing. The higher price and the lack of generic alternatives mean a more lucrative product — especially when states require insurers to cover the cost of abuse-deterrent drugs.
The Associated Press reported last year that drugmakers were heavily lobbying states to adopt these kinds of pro-ADF opioid laws.
For insurers and the healthcare system, though, widespread adoption of brand-name ADF opioids could be financially unsustainable.
According to a post on the “Health Affairs” blog, if the U.S. Department of Veterans Affairs switched to prescribing only abuse-deterrent opioids, its yearly spending for opioids would increase from $100 million to around $1 billion.
“Branded ADFs cost much more than generic non-ADF products,” Cohen told Healthline. “In many instances, payers have balked at reimbursing branded ADFs due to cost. Thus, having generic — cheaper — versions of ADFs may improve patient access.”
The FDA outlined several steps for speeding up the development of generic abuse-deterrent opioids.
The agency plans to help companies navigate the regulatory process in order to produce abuse-deterrent opioids sooner.
In its guidance, the FDA also provided recommendations for the types of studies that drugmakers could do to ensure that generic drugs are just as abuse-deterrent as brand-name versions.
Gottlieb emphasized that this isn’t a push by the FDA to “encourage more opioid use.” Instead, the agency hopes to shift opioid prescribing toward abuse-deterrent versions — but “only when opioids are clinically appropriate.”
Although ADF opioids can have a role in reducing the number of new addictions, they have limits.
“ADFs are not a panacea,” said Cohen. “They are opioids and, therefore, potentially addictive.”
This isn’t always clear to patients or doctors.
Dr. David Fiellin, director of the Program in Addiction Medicine and professor of medicine, emergency medicine, and public health at the Yale School of Medicine, pointed to a
Researchers found that many primary care physicians “believe that medications that were described as ‘abuse-deterrent’ were less likely to cause addiction than those that are not abuse-deterrent,” Fiellin told Healthline.
This isn’t the case. Also, abuse-deterrent doesn’t mean “abuse proof.”
ADF opioids may be harder to misuse by crushing or dissolving them. But people can still swallow the pills whole.
“The most common way that medications such as prescription opioids are used in a non-medical fashion is just by swallowing them,” said Fiellin.
“So the mechanisms that are in place that make these medications resistant or abuse-deterrent do not impact the most common route of administration, which is orally and swallowing,” he added.
In spite of their lower cost, generic ADF opioids by themselves won’t be enough to reverse the opioid epidemic.
The use of generic ADFs has “the potential to impact the costs associated with the delivery of those medications,” said Fiellin, “but I think it misses the opportunity to change — in a substantial way — the overall environment and use of these medications, and the overprescribing of these medications.”
Many efforts have been made in recent years to tackle the overprescribing of opioids, which is a
Fiellin sees two areas that would likely have a “larger impact than a sole focus on abuse-deterrent formulations.”
The first is “reducing the overall level of opioid prescribing” so that it’s consistent with the scientific literature.
The potential risks and benefits of opioids also need to be carefully weighed. This includes risks to society such as prescription opioid pills being given or sold to other people, what’s known as diversion.
The CDC also highlights that there is little scientific evidence to support the widespread use of opioids for chronic pain.
“While some patients clearly benefit from long-term opioid therapy for chronic pain, many do not,” said Fiellin.
Long-term use of prescription opioids — even when taken as prescribed by a doctor — also carries risks. These include heart and breathing problems, opioid misuse, and opioid use disorder.
Abuse-deterrent opioids may reduce the number of pills that end up in the wrong hands. But they won’t reduce the potential physical effects.
Fiellin pointed to another area that would have a large impact — making sure that people with an opioid use disorder have “consistent and ready access to evidence-based treatments, such as buprenorphine or methadone, or even extended-release naltrexone.”
This is important because people who are already using illegal opioids such as heroin or fentanyl won’t be helped by the introduction of abuse-deterrent prescription opioids.
As well, when ADF opioids show up on the market — and the non-ADF opioids become scarcer — people may transition to heroin, fentanyl, or other illegal opioids. This was seen when the
At the root of the epidemic — or one of many roots — is that we need better ways to treat chronic pain. We also need to recognize that opioids aren’t the only option available to doctors and patients.
“While attempts to create opioids that are harder to use in a non-prescribed way are important,” said Fiellin, “strategies that support non-opioid treatment of chronic pain are also likely to have an impact on the epidemic.”