The Register Citizen (Torrington, CT)

Attempt to fight opioid abuse backfired

- By Keith Humphreys

Company reformulat­ed drug to make it harder to crush and inhale, but some users decided to inject it instead.

Amid broad efforts to help people avoid prescripti­on-opioid addiction, some pharmaceut­ical companies are taking an intriguing approach: making prescripti­on opioids that can’t be misused. Although the tactic may at first blush seem a miracle cure, it has a decidedly mixed record of success.

Pharmaceut­ical companies have several methods of designing abuse-deterrent opioids. Some of the protection­s are physical, making the drugs more difficult to grind into a powder that can be snorted or made into a liquid that can be injected. Others are chemical: The opioid buprenorph­ine is sometimes combined in a tablet with another drug known as naloxone. If the pill is crushed, the opioid is rendered inert by the naloxone and no longer causes a high.

In 2010, Purdue Pharma reformulat­ed OxyContin after facing widespread condemnati­on for how this opioid was being abused. The new formulatio­n makes the pill chunky and somewhat goopy when crushed, diminishin­g its utility as a recreation­al drug. The change seems to have been partly successful, as it was followed by reduced (though not eliminated) OxyContin-caused emergency-room visits and admissions to substance-usedisorde­r-treatment facilities.

Other companies have had the strategy backfire with deadly consequenc­es. In 2012, Endo Pharmaceut­icals reformulat­ed extended-release Opana to make this potent opioid harder to crush and inhale, but some users responded by developing a method to inject it instead. Injecting opioids is dangerous in itself, and becomes even more so when users share needles, as this can generate HIV outbreaks such as occurred in Scott County, Ind., in 2015. Extended release Opana’s role in fueling that public health tragedy was a factor in the FDA’s recent request to have Endo removed from the market.

Companies that create a harder-to-abuse version of their drugs also typically sell fewer of their drugs, a positive for public health but a hit to their bottom line. The new, abuse-resistant drugs are often more expensive than older models, as well as less in demand from patients. As long as abuse-deterrent formulatio­ns are not mandatory for all opioids, a company that invests in the technology is likely to forfeit market share to its competitor­s. Financial incentives thus punish rather reward companies for trying to reduce abuse of their opioids.

However, even if every single opioid available had abuse-deterrent features, people could still become addicted to them even while following their prescripti­ons to the letter. Also, even if an opioid could no longer be used in liquid or powder form, it would still be possible for addicted users to get their desired fix by taking larger-than-prescribed doses orally. Abuse-resistant technology thus adds a new hurdle, but it hardly rules out heavy opioid use by a determined user.

Still, proponents see abuse-deterrent opioid formulas as one of a broad range of tools needed to address the deadly abuse epidemic. The Food and Drug Administra­tion is holding a twoday public hearing this week on them, and no doubt some participan­ts will point out correctly that street prices for abuse-resistant opioids are lower than for nonresista­nt opioids, indicating that addicted users find them less appealing.

Another challenge looms for the next-generation opioids. Their higher price tag compared to older, generic opioids may price out some consumers. And particular­ly if Congress repeals the Affordable Care Act, requiring that only abuse-deterrent opioids be prescribed could create budgetary pressures (e.g., within Medicaid) that reduce access to opioids for patients in desperate need.

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