FDA Releases Final Guidance for Abuse-Deterrent Opioids

FDA Releases Final Guidance for Abuse-Deterrent Opioids

Pharmaceutical companies that make abuse-deterrent opioid painkillers have received the final word from the Food and Drug Administration (FDA) on the types of studies and evaluations required to win official "drug-deterrent" approval. The drug companies were first made aware two years ago that new guidelines about abuse-deterrent drugs and labeling were on the way. The FDA released an early draft back in January 2013, outlining what kinds of studies would be needed to win approvals for abuse deterrent opioids and for labeling the new formulations. Abuse-Deterrent Opioids - Evaluation and Labeling, Guidance for Industry, was released this past April by the FDA's Center for Drug Evaluation and Research (CDER). The FDA guidelines "don't establish legally enforceable responsibilities," the document says. "Instead, guidances (sic) describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited." The details of the new guidelines are rather technical and intended for pharmaceutical companies, so we aren't going to go into those in this report. However, we can say that the guidelines do not mandate that all new opioids must employ some sort of abuse-deterrence. They only describe in detail exactly what the Agency considers to be the best approaches to abuse deterrent opioids and labeling.

'Abuse deterrence' is a coveted labeling claim

Labeling is more stringently under the control of the FDA than the technology employed for abuse deterrence. You can't simply write a label that makes claims about abuse deterrence or any other aspects of the drug, without first submitting to the FDA's guidelines and receiving some level of approval. The new guidelines outline what labeling claims may be approved, based on the results of the studies. Approved labels will be sorted into four categories depending on the level of evidence of their abuse-deterrent properties. Receiving approval to label your drug as "abuse-deterrent" has become a highly desirable marketing claim among opioid painkiller manufacturers and marketers. But the new guidelines clearly explain that it's not all about marketing: "Including information about a product's abuse-deterrent properties in labeling is important to inform health care professionals, the patient community, and the public about a product's abuse potential," the FDA said. "Accordingly, FDA encourages sponsors to propose labeling that sets forth the results of in vitro, pharmacokinetic, clinical abuse potential and formal postmarket studies and appropriately characterizes the abuse-deterrent properties of a product."

FDA avoids a $20-million penalty in executive salaries

By releasing the new guidelines in April, the FDA easily beat a June 30th deadline set by Congress last year. Failure to make the end of June deadline would have meant a $20-million cut in funding for salaries and expenses in the FDA commissioner's office, instead giving those funds over to the criminal investigations department to combat drug diversion. The penalty was included as an amendment by Hal Rogers (R-Ky) to the "Cromnibus" appropriations bill passed last December. Rogers, chairman of the House Appropriations Committee, was a logical champion for such a threat. Kentucky is one of the states seriously affected by the opioid painkiller and heroin epidemic raging across the nation. Kentucky is also leading many other states with various programs to combat the epidemic, and badly wants to see better abuse deterrence built into opioid painkillers.

So far there's only six abuse-deterrent opioid painkillers

Currently, six opioid painkiller brands incorporate abuse deterrent properties and are on the market - four with FDA approval to say so on their labels. All are extended release (ER) formulations. Purdue Pharma has approved labeling for "Targiniq ER" (oxycodone and naloxone), "Hysingla ER" (hydrocodone bitartrate) and Oxycontin (oxycodone). And Pfizer has approved labeling for Embeda, a morphine-and-naltrexone formulation. Two others, "Opana ER" (oxymorphone) from Endo, and "Zohydro ER" (hydrocodone) from Zoegenix but now sold by Pernix, both have abuse-deterrent formulations but have not received FDA approval for their labels. According to a report in MedPage Today, the FDA's deputy director of regulatory programs, Douglas Throckmorton, MD, said the agency is working with 30 companies interested in developing abuse-deterrent opioids, and is focused on supporting development of such products. The report added that the agency has not yet released its abuse-deterrent guidelines for generic drug formulations, which were not subject to the June 30 deadline imposed by Congress. Dan Cohen, chairman of the Abuse Deterrent Coalition, told MedPage Today that the guidance is a "positive first step," and added that his organization will "continue to advocate that all Schedule II drugs should be required to have an FDA-approved abuse-deterrent formulation."

What does the FDA mean by "abuse deterrent"?

In case you haven't already read about abuse deterrent opioids, it involves creating a tablet that embeds the active ingredient in a matrix of materials that make it very difficult to crush the pill for snorting or to dissolve it for injecting. Here's the FDA's statement on what it means by abuse deterrent: "Because opioid products are often manipulated for purposes of abuse by different routes of administration or to defeat extended-release (ER) properties, most abuse-deterrent technologies developed to date are intended to make manipulation more difficult or to make abuse of the manipulated product less attractive or less rewarding. It should be noted that these technologies have not yet proven successful at deterring the most common form of abuse-swallowing a number of intact capsules or tablets to achieve a feeling of euphoria. "Moreover, the fact that a product has abuse-deterrent properties does not mean that there is no risk of abuse. It means, rather, that the risk of abuse is lower than it would be without such properties. Because opioid products must in the end be able to deliver the opioid to the patient, there may always be some abuse of these products. "For purposes of this guidance, abuse-deterrent properties are defined as those properties shown to meaningfully deterabuse, even if they do not fully prevent abuse."

Are these abuse deterrent opioid painkillers working?

So far, no drug company has come up with a formulation even remotely "abuse proof." And determined addicts continue to find various ways to overcome the deterrent technologies currently in use. Deterrent-busting discoveries are shared rapidly with others via the internet. So how good is the current abuse-deterrent technology? Picture an overweight, out-of-shape, middle-aged, donut-munching rent-a-cop, and you'll get an idea of the current level of protection offered by current abuse deterrence. He might be a deterrent against a snatch-and-grab by a stoned teenager at the mall. But he isn't who you want protecting your life against a Ninja assassin. The assassin in question is an extended release opioid painkiller being crushed and then snorted or injected - an entire day's worth of opioids all at once. And thousands of determined opioid addicts across the country defeat deterrent technology every day, and risk their lives every time. There is some early evidence that the current levels of abuse deterrence are having some positive results, but not to the most determined addicts. And the flip side is that abuse deterrence is sending thousands of other addicts from prescription opioids to heroin, which is as much as 15 or more times cheaper than pills.

The problem really isn't the pills, it's the pill abusers

We all know that at the bottom of it all, pills don't make addicts. Addicts make addicts. As in the old adage, 'guns don't kill people, people kill people,' the psychology of it all is a story for another day. Right now, we're just talking about the guns- in our case, the pills. And the opioid problem goes far beyond those six abuse-deterrent brands of opioids. There are dozens of opioid painkillers, dozens of pills, patches, injectables, inhalants, insertables - all sorts of them. And they're all considered not just useful but sometimes even indispensable for certain patients with certain conditions at certain times by many, if not most, doctors. Although, to be fair, a growing number of physicians are beginning to speak up against the opioid product overload. Nevertheless, these dozens of opioid formulations are on the shelves, ready to be used or abused, all capable of creating dependence, addiction and overdose. Every day, 46 people die from an overdose of prescription painkillers - more than 16,000 tragically needless and avoidable deaths every year. It's a shocking and staggering statistic. It exceeds all other accidental causes of death in the country. Here at Novus, we're doing everything we can to help turn back the tidal wave of destruction being wrought on America by opioids. Our patients are winning and getting their lives back. We continue to develop and perfect state-of-the-art medical opioid detox protocols that are far beyond what's in use almost everywhere else. Don't hesitate to call for more information and advice. We're always here to help.

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