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OxyContin Abuse-Deterrent Postmarketing Data Are In. Now What?

 
• By Brenda Sandburg

Purdue’s postmarketing studies leave many unanswered questions about reformulated OxyContin, including the ‘million-dollar’ question of its impact on addiction. Advisory committee members ask for clarity on what constitutes ‘meaningful reduction’ in abuse and advise FDA on what to tell the public about the data.

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FDA to decide how to convey results of reformulated OxyContin postmarketing studies • Source: Shutterstock

After regulatory review and advisory committee voting on Purdue Pharma L.P.’s postmarketing studies, many questions remain about the abuse-deterrent formulation of OxyContin (oxycodone). Most notably, does the reformulation have an impact on addiction and public health? How will the US Food and Drug Administration communicate the results of the studies to physicians and the public? And does it even matter that abuse-deterrent formulations of opioids are on the market?

The FDA encouraged opioid makers to reformulate their products to include abuse-deterrent properties in hopes they might help mitigate opioid misuse. But 10 years after approval of reformulated OxyContin, the market has changed. Most opioids with abuse-deterrent labeling approved after OxyContin’s reformulation never launched or were withdrawn from the market as manufacturers found it was not worth selling them

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