Abuse-Deterrent Labeling for Opioid Drug Embeda Gets FDA Nod

The FDA has announced that the opioid drug Embeda will now have an acknowledgement of its abuse-deterrent properties on its label. According to the new label, Embeda has properties expected to reduce abuse of the drug when it’s crushed, but the protection against abuse is far from perfect. Finding out more about the drug, the limitations to its abuse-deterrent properties and the overarching problems with this strategy for reducing prescription drug abuse reveals both the benefits of the new decision and its potential to lead to unfortunate consequences. In short, the prescription drug abuse epidemic is highly unlikely to be stemmed by changes to the drugs themselves; a more wide-reaching approach seems to be required.

What Is Embeda?

Embeda is a combination of morphine sulfate and naltrexone hydrochloride (manufactured by Pfizer) in extended-release capsules. The morphine component of the drug is the potentially-addictive but pain-relieving element (which is chemically closely related to heroin), and the naltrexone is a drug that blocks the effects of opioids. The drug is intended to be used only for severe pain that requires long-term, round-the-clock treatment, and even then it’s only recommended when other treatment options are inadequate. It shouldn’t be used for as-needed pain relief and is not approved for such usage.

Embeda’s Abuse-Deterrent Properties

When Embeda is taken as directed (by swallowing the pill), only the morphine component of the drug is released, providing the pain relief medical users need unfettered by the potential effect of the naltrexone. However, many prescription drug abusers crush extended-release tablets to get a larger, abuse-friendly dose in a shorter period of time. With Embeda, when the drug is crushed, the naltrexone becomes active and thereby reduces the euphoric effects of the morphine. If somebody is dependent on opioid drugs, this blocking of the substance’s effects may cause her to go through withdrawal. The process isn’t perfect, but this is largely the reason for the new abuse-deterrent labeling.

However, taking the drug orally without crushing is still a viable method for abuse, because then the naltrexone doesn’t have much of an effect. In short, simply taking too much is still a method of using the substance to get high, which represents a serious flaw in the abuse-deterrent claim. Additionally, the FDA notes that it’s unclear whether these abuse-deterrent properties will have any impact on the intravenous abuse of the drug.

When the drug was released, studies were conducted to determine whether it genuinely had abuse-deterrent properties. Abuse-liability studies successfully demonstrated the benefits of the formulation of the drug when the tablets were crushed and either abused orally or snorted, but the evidence for deterring intravenous abuse wasn’t as strong. That part of the study involved a simulation of the quantities of morphine and naltrexone users would expect to release when they crushed the drug rather than a directly true-to-life test. Although the study showed that it was less “liked” as a drug and produced a smaller high than morphine alone, it isn’t clear whether this will translate to less intravenous abuse in the real world.

Why Abuse-Deterrent Drugs Aren’t the Answer

Before critiquing the approach on broader grounds, it’s worth noting that any extra tool that can help reduce abuse of a substance can be a useful addition to the efforts to curb prescription drug abuse. The real problem is that strategies like this—if used alone—are wholly inadequate for addressing the true issue of addiction. Simply put: if you’re addicted to opioids but find that you can’t abuse Embeda in the same way you used to, is it really realistic to say you’ll magically overcome your addiction as a result? Can the whole problem of opioid addiction be subverted by reducing the abuse liability of specific substances?

Of course not, because there are other opioids that people can abuse. The problem is perfectly demonstrated by the impact of the abuse-deterrent form of OxyContin, a similar medicine. The changes to the formula were actually effective in reducing OxyContin abuse, with the percentage of drug abusers selecting OxyContin as their primary drug decreasing from 35.6 percent prior to the change to just 12.8 percent afterward. However, this change in preference was counterbalanced by a switch to other opioid medicines (such as fentanyl and hydromorphone), for which the corresponding rates rose from 20.1 to 32.3 percent over the same period. Most disturbingly, the number of respondents using heroin to get high in the past 30 days almost doubled.

The reason for this is disarmingly simple: addiction itself is the issue rather than one specific drug. If somebody struggles to cope with stress, depression or other unpleasant emotions and, instead of using healthy strategies to boost her mood, runs to substances regularly enough to become dependent, taking away one source of the high is virtually meaningless. Like the users in the OxyContin study, an addict can find another substance to use as a self-destructive coping mechanism easily enough.

Fixing Addiction Is Hard; Changing a Pill Is Easy

It goes without saying that if all opioid medicines had abuse-deterrent properties, the prescription drug epidemic would show signs of abating. However, as evidence shows, there’s a good chance that many of those would-be pain pill abusers would just make the switch to something harder. Prescription drug abuse would be beaten, but addiction would continue as strongly as ever. With that in mind, the updated labeling for Embeda is put firmly into context. Making something abuse-deterrent isn’t too tough, but unfortunately it’s not sufficient to solve the problem. Rather than worrying about establishing abuse-free medications, we need to start asking tough questions about what’s at the root of the addiction problem in the U.S. and to help more people get into treatment. It isn’t as simple, but if we take those steps, it will be considerably more effective.

Posted on January 28th, 2015

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