One potentially important step towards the goal of creating safer opioid analgesics has been the development of opioids that are formulated to deter abuse. Abuse-deterrent properties are defined as those properties shown to meaningfully deter abuse, even if they do not fully prevent abuse. The term abuse is defined as the intentional, non-therapeutic use of a drug product or substance, even once, to achieve a desirable psychological or physiological effect. The FDA considers the development of these products a high public health priority.

An example of “abuse-deterrent properties” would be physical barriers that can prevent chewing, crushing, cutting, grating, or grinding of the dosage form. Chemical barriers, such as gelling agents, can resist extraction of the opioid using common solvents like water, simulated biological media, alcohol, or other organic solvents. Physical and chemical barriers can limit drug release following mechanical manipulation, or change the physical form of a drug, rendering it less amenable to abuse. An opioid antagonist can be added to interfere with, reduce, or defeat the euphoria associated with abuse. Substances can be added to the product to produce an unpleasant effect if the dosage form is manipulated or is used at a higher dosage than directed. Certain drug release designs or the method of drug delivery can offer resistance to abuse.

Collegium Pharmaceutical Inc’s experimental opioid painkiller Xtampza moved one step closer to approval this month after a panel of outside advisers to the U.S. Food and Drug Administration unanimously voted in favor of the drug. The FDA panel’s vote of approval for Xtampza is also a positive for other companies developing abuse-deterrent version of painkillers. Pernix Therapeutics Holdings Inc, Egalet Corp, KemPharm Inc, IntelliPharmaCeutics International Inc, Pain Therapeutics Inc and Acura Pharmaceuticals Inc are among the drugmakers developing abuse-deterrent painkillers.

The FDA has already approved Hysingla, made by Purdue Pharma, which also makes OxyContin. Hysingla is a “pure” hydrocodone drug, unlike Vicodin, which contains a combination of short-acting hydrocodone and acetaminophen.

Earlier this year, the FDA approved Targiniq ER, a painkiller that combines oxycodone and naloxone. The naloxone blocks the euphoric effects of oxycodone, making it less appealing to abuse. Targiniq ER, also made by Purdue Pharma, can be crushed and then snorted or injected. If the pills are crushed, the naloxone becomes active.

The FDA recently approved new labeling for the opioid painkiller Embeda that states the drug has abuse-deterrent features. The label will indicate Embeda has properties expected to reduce abuse of the drug when it is crushed and taken orally or snorted. The drug can still be misused if it is swallowed intact. Embeda contains morphine and naltrexone, and comes in extended-release capsules.

“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” said FDA Commissioner Margaret A. Hamburg, M.D. “We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”