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Abuse-Deterrent Immediate-Release Opioids

June 11, 2017 by comitsol

Although RoxyBond is not the first abuse-deterrent oxycodone immediaterelease (IR) product, it is different. In April 2017, RoxyBond gained FDA approval based on manufacturer claims that the drug has qualities that are effective against nasal or intravenous (IV) abuse. The approval was not unanimous, however, especially on the question of whether the formulation could significantly deter IV abuse of the drug.

The development of abuse-deterrent formulations for IR Class II (CII) drugs could be very significant. Because these medications are far more prescribed and abused than extended-release (ER) versions, offering an abuse-deterrent IR product could have a huge effect on prescription drug diversion.

None of the ER abuse-deterrent medications are perfect. Multiple tablets can be taken at the same time to try to achieve a high, but hardened abusers are primarily satisfied through the nasal or IV route. These individuals are typically more prone to overdose and death.

Heroin, fentanyl, and carfentanil abuse is rampant in our country, but many individuals think that addiction to these drugs started with prescription drug abuse. If it did, IR products are likely the main source. Oxycodone and hydrocodone generic drugs are widely prescribed, have no abuse-deterrent properties, and are cheap compared with their ER cousins.

Brand drug makers have long complained that they must “jump through multiple hoops” to obtain approval of their CII abuse-deterrent drugs and that generic makers produce IR products without the same scrutiny. Generic makers respond to this complaint by saying that the cost factor of producing abuse-deterrent IR drugs would put them out of the marketplace—and it likely would. Any new CII IR drug with abuse-deterrent properties would undoubtedly be expensive, like ER oxycodone, as makers try to recoup their massive expenses associated with these products.

There is no question that OxyContin, before its reformulation, was one of the top drugs of abuse and diversion, especially for hardened addicts. But the drug’s popularity has declined since 2010, as the reformulation has been highly successful. This development drove abusers to oxycodone IR, a much cheaper drug in the retail market, but just as expensive as OxyContin, as street prices are close to $1 per milligram. Although the IR version is not available in an 80-mg tablet, abusers can pool three 30-mg doses to provide the same high, easily snorting or injecting the generics.

If the trend of creating abuse-deterrent versions of IR generics continues, pain relief will undoubtedly become more expensive. I don’t see IR oxycodone, as it exists today, going away soon, if ever, but if these new drugs work, there may be pressure to prescribe and dispense them, like some of the ER CII pharmaceuticals. Insurance carriers will continue to push back on this, as the debate continues.

Regardless, legitimate pain patients are likely to carry the brunt of the burden, whether it is financial due to pressure on practitioners to prescribe and dispense these new medications or in the form of questioning because they cannot afford the abuse-deterrent options and want the IR equivalents. Because the vast majority of consumers of controlled substance pharmaceuticals are legitimate patients who take them as prescribed, they seem to consistently take the backseat when abuse and diversion are involved.

I applaud pharmaceutical manufacturers who pursue new formulations that reduce abuse and diversion, although they have been accused of starting and fueling our current heroin crisis. Having effective pain medications that are difficult to abuse benefits those whom we should be trying to protect: pain patients.

Filed Under: Abuse Prevention, Drug Diversion, Pharmacy Times Article

News Topics

  • Abuse Prevention (67)
  • Drug Diversion (117)
  • Health Care Facilities (43)
  • Pain Management (39)
  • PDE News (2)
  • Pharmacies (25)
  • Pharmacy Times Article (70)
  • Uncategorized (1)

How BIG is the problem?

Year after year, state and local law enforcement statistics indicate that pharmaceuticals are almost 30% of the overall drug problem in the United States, running a close second only marijuana abuse. However, until recently, law enforcement, health care professionals, and the general public have placed little emphasis on this huge problem.

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About PDE

Pharmaceutical Diversion Education (PDE) is designed to assist a wide range of the population in understanding the potential abuse and addiction that can be associated with prescription medication.

Drug Diversion:
Any Criminal Act Involving a Prescription Drug.

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Areas of Discussion

  • Abuse Prevention (67)
  • Drug Diversion (117)
  • Health Care Facilities (43)
  • Pain Management (39)
  • PDE News (2)
  • Pharmacies (25)
  • Pharmacy Times Article (70)
  • Uncategorized (1)

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