FDA Approving More Abuse-Deterrent Opioids

In 2015, the FDA issued a Guidance to Industry report that outlined recommendations for conducting studies evaluating abuse-deterrent formulations of opioids.
In 2015, the FDA issued a Guidance to Industry report that outlined recommendations for conducting studies evaluating abuse-deterrent formulations of opioids.

LAS VEGAS—Opioid abuse is rising and drives much of the increase in drug poisoning deaths that have occurred over the past 15 years. Opioid overdoses account for more than 60% of drug overdose deaths and were associated with the deaths of 28,000 people in 2014.1 Today, 4 times as many prescriptions for opioids—such as hydrocodone, oxycodone, and methadone—are being dispensed as in 1999, and opioid overdose deaths have quadrupled since that time, as well.2

In response to the opioid abuse epidemic, the US Food and Drug Administration (FDA) made it a priority to support the pharmaceutical industry in developing abuse-deterrent formulations (ADF) of currently approved, generic opioids. In 2015, the FDA issued a Guidance to Industry report that outlined recommendations for conducting studies evaluating the abuse-deterrent properties of ADF opioids.3

While ADFs of opioids may help mitigate the risk of opioid abuse, they have limitations as well. Jeremy Adler, PA-C, Senior Pain Management PA with Pacific Pain Medicine Consultants in California, discussed the technology and issues behind ADFs of opioids in his presentation, “Abuse-Deterrent Opioids,” at PAINWeek 2016. Mr Adler is a co-author for the 2009 American Pain Society–American Academy of Pain Medicine Opioids clinical practice guidelines and developed the California Academy of PAs Controlled Substance Education Course.

He noted that several new abuse-deterrent formulations of opioids have become available since 2010, including OxyContin, Targiniq ER, Embeda, Hysingla ER, MorphaBond, Xtampza ER, and Troxyca ER. It is important to take into account all patient factors before prescribing any of these medications, Mr Adler explained. 

“Even when abuse-deterrent opioids are used appropriately, there are still inherent risks. The patient needs to be appropriately selected for and monitored during treatment,” Mr Adler told Clinical Pain Advisor. “We have yet to develop a medication that limits people from just taking more of it, which is the most common way that these drugs are abused.”

To illustrate his point, Mr Adler compared abuse-deterrent opioids with the advances in safety technology in the motor vehicle industry. “We've seen improvement in the safe operation of motor vehicles with the use of technology, yet we still don't have the ability to have an impaired driver operate a motor vehicle safely,” he said.

During the presentation, Mr Adler discussed strategies that ADF opioids employ to prevent patients from abusing the agents by crushing and snorting, smoking, or injecting the drugs or by simply taking more than the prescribed dose. He covered opioid agents that use physical and chemical barriers, aversion substances, new molecular entities and prodrugs, agonist/antagonist combinations, and delivery systems to deter patients from manipulating opioids for misuse.

Recent data suggest that abuse-deterrent opioids may be effective at reducing opioid abuse. In one postmarket study of the ADF of OxyContin, reports of OxyContin abuse decreased by 48% in national poison center surveillance systems, doctor-shopping was reduced by 50%, and overdose fatalities that were reported to the manufacturer decreased by 65%.4

"I believe this should be a priority, using these new technologies as a way to provide those patients [who] need this type of medication access to it while at the same time discouraging people who seek out these medications for nonmedical purposes," Mr Adler said during his talk.

Sources

1. Centers for Disease Control and Prevention. Injury prevention & control: opioid overdose. Data overview. Available at: http://www.cdc.gov/drugoverdose/data/index.html. Updated 2016. Accessed September 2, 2016.

2. Centers for Disease Control and Prevention. Injury prevention & control: Opioid overdose. Understanding the epidemic. Available at: http://www.cdc.gov/drugoverdose/epidemic/index.html. Updated 2016. Accessed September 2, 2016.

3. Food and Drug Administration. Abuse-deterrent opioids—evaluation and labeling: guidance for industry. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm334743.pdf. Published 2015. Accessed September 2, 2016.

4. Coplan PM, Chilcoat HD, Butler SF, et al. The effect of an abuse-deterrent opioid formulation (OxyContin) on opioid abuse-related outcomes in the postmarketing setting. Clin Pharmacol Ther. 2016;100(3):275-286.

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