FDA Offers New Guidelines for Abuse-deterrent Drugs


The term “abuse-deterrent” in prescription drugs refers to special formulations that make it harder for addicts to alter medications for their own use. For example, a tablet of oxycontin may be ground up by someone addicted to opiates so that he or she can dissolve and inject the drug, defeating the purpose of dosing in an extended release tablet.

The FDA regulates what can and cannot be used in prescription drugs, and until now, each type of abuse-deterrent form has had to clear regulatory hurdles on its own. New draft guidelines from the FDA should make the process smoother and pave the way toward prescription medications that work the same for legitimate patients but are much harder to alter for street use.

Less attractive to addicts

The guidelines are not specific directions for manufacturers, but a road map. The purpose is to standardize tests that need to be done before marketing something as "abuse-deterrent" and how the FDA will evaluate data submitted. The important thing is to clear the air and give manufacturers an incentive to make their drugs less attractive to illegal users.

The two main ways that prescription opioids are abused by addicts are by crushing into a powder fine enough to snort up the nose and by dissolving the active ingredient in water and injecting it. One technique used to block these methods is to put other, normally inactive ingredients in the pill that would interfere with any dosing method that avoids the stomach. An addict who snorted or injected the pill would get a dose of the otherwise inactive ingredient – usually a substance that blocks the “high.”

A second method is to bind the narcotic into a water-insoluble matrix – a resin or polymer. This type cannot be dissolved in water and won’t release the opioid quickly, even if crushed. This time-delay action stops the immediate rush that addicts crave.

More attractive to doctors

The guidelines are currently in a comment period, allowing the FDA to receive input from the industry and other concerned parties. If adopted, the guidelines also encourage manufacturers to develop other abuse-deterrence formulations.

There’s a real incentive here if the FDA clears out the hurdles. Drugs that are formulated to prevent abuse are more attractive. They sell better and offer a way for drug makers to gain market share. Doctors don’t want to contribute to the diversion of prescription drugs into the illegal market, and they will prescribe abuse-deterrent forms if they are available.


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