FDA approves more abuse-deterrent opioids, but questions remain about their value

Experts are split on whether opioids with abuse-deterrent properties are the best answer to the prescription opioid abuse epidemic

At the start of 2017, FDA approved two new abuse-deterrent opioids. Morphine sulfate (Arymo—Egalet) extended-release (ER) was given agency approval for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment when alternative treatment options are not adequate. Shortly thereafter, FDA approved hydrocodone bitartrate (Vantrela ER—Teva) for the same indication.

In recent years, FDA has also approved hydrocodone bitartrate (Hysingla ER—Purdue Pharma) and morphine sulfate and naltrexone hydrochloride ER (Embeda—Pfizer), which was originally submitted by King Pharma and later acquired by AlPharma but withdrawn from the market. FDA considers ER medications to be more prone to abuse because they pack in higher doses, which is why many are now abuse deterrent.

But experts are often split on whether opioids with abuse-deterrent properties are the best answer to the prescription opioid abuse epidemic. Abuse-deterrent opioids are formulated to make them more difficult to crush or dissolve for quicker highs by injecting, snorting, or oral dose dumping, but they are not foolproof. They simply mitigate the temptation for product manipulation.

 “Some people think they are a godsend, and some people think they are a gimmick,” said Jeffrey Fudin, PharmD, DAIPM, FCCP, FASHP, president and director of scientific and clinical affairs at Remitigate LLC.

According to a recent report from the Center for Public Integrity in partnership with the Associated Press (AP), manufacturers of abuse-deterrent opioids have spent more than $20 million on federal lobbying efforts that included legislation promoting drugs with these formulations between 2012 and 2015. The report points to several other ways abuse-deterrent opioids are lucrative for the pharmaceutical industry. For instance, the researchers found that opioids made with abuse-deterrent technology represented fewer than 5% of all opioids prescribed in 2015 but generated more than $2.4 billion in sales, which is roughly a quarter of the entire U.S. market for opioids.

However, many believe abuse-deterrent opioids are a step in the right direction, with the caveats that technology could improve and health professionals need to do a better job of selecting and educating patients who are taking these medications.

Researchers from the RAND Corporation and the Wharton School tied the heroin epidemic in the United States to the introduction of the abuse-deterrent version of oxycodone hydrochloride (OxyContin—Purdue Pharma)—the first drug to receive that designation from FDA in 2010. Using data from the National Survey on Drug Use and Health, researchers isolated states with high OxyContin misuse to home in on substitution patterns after the reformulation.

“We estimate large differential increases in heroin deaths immediately after reformulation in states with the highest initial rates of OxyContin misuse,” said the working paper, which was published by the National Bureau of Economic Research.

The authors concluded that a substantial share of the increase in heroin deaths since 2010 can be attributed to the reformulation of OxyContin.

Visit www.pharmacytoday.org for the full article in the upcoming March 2017 issue of Pharmacy Today.