Regulatory Focus™ > News Articles > Drug Reformulations Lead to Shifting Patterns of Abuse

Drug Reformulations Lead to Shifting Patterns of Abuse

Posted 12 July 2012 | By Alexander Gaffney, RAC 

A report in the New England Journal of Medicine (NEJM) found abuse of a OxyContin, a branded version of the opioid oxycodone, went down significantly between 2010 and the first quarter of 2012 as the result of a new time-release formulation released in August 2010 by Purdue Pharma. The reformulation made it more difficult to turn the medicine into a powder, thereby reducing an abuser's ability to snort or inject the medication.

The article, by Theodore Cicero, PhD, of Washington University and Hilary Surratt, PhD, of Nova Southeastern University, found a 22.8% reduction in the number of abuse cases in just 21 months after the crush-resistant formula was released.

Shifting Patterns of Abuse

But in cutting down on OxyContin's ability to be abused, the drug's manufacturer may have inadvertently driven abusers into seeking other forms of the drug to abuse, says Cicero.

"Simultaneously, selection of hydrocodone and other oxycodone agents increased slightly, whereas for other opioids, including high-potency fentanyl and hydromorphone, selection rose markedly, from 20.1% to 32.3% (P=0.005)," wrote Cicero. "Of all opioids used to "get high in the past 30 days at least once," OxyContin fell from 47.4% of respondents to 30.0% (P<0.001), whereas heroin use nearly doubled."

Sixty-six percent of abusers interviewed by Cicero and Surratt said they had switched to using another opioid to abuse in light of the change, with many switching to heroin. "It is important to note that there was no evidence that OxyContin abusers ceased their drug abuse as a result of the abuse-deterrent formulation," remarked the authors. "Rather, it appears that they simply shifted their drug of choice."

It's little wonder then that the abuse of other painkillers is skyrocketing. A USA Today report indicates Opana,(oxymorphone), also an opioid, has overtaken oxycodone as being the most abused drug in the US.

The US Food and Drug Administration (FDA) seems to have taken notice as well, instituting a class-wide Risk Evaluation and Mitigation Strategies (REMS) policy applicable to all opioid drugs. Though the policy relies primarily on continuing medical education (CME) for doctors instead of mandatory abuse prevention methods, the agency said it hopes the policy will address the "complex problem" of opioid abuse.

The agency also announced last week its intent to crack down on unapproved oxycodone products, and said the products constitute a "high public health priority" partially as a result of their "potential for addiction."


Read more:

NEJM - Effect of Abuse-Deterrent Formulation of OxyContin


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