An FDA advisory panel will be voting on whether or not Purdue Pharma's abuse-deterrent formulation (ADF) of oxycodone (OxyContin) "meaningfully reduced" opioid-related overdoses and deaths since it was introduced in the market 10 years ago.
The FDA's Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products advisory committees are set to meet jointly to review the findings from four postmarketing studies conducted by Purdue investigating whether or not the ADF OxyContin lowered the risk of adverse outcomes related to opioid abuse.
The manufacturer, and the public panel members after hearing presentations from the FDA, will discuss and vote on whether the ADF OxyContin, which was introduced in 2010 in the form of tablets made to be hard to crush or dissolve that replaced a previous version, easy to snort or inject for a quick high, resulted in a reduction of abuse or had any unintended adverse consequences, and its overall impact on public health.
Agency staff found that reformulated OxyContin could have led to a decrease in abuse by "non-oral routes," according to an 888-page FDA briefing document created for panel members.
But little good evidence was found that the product made a substantial dent in overall abuse.
Other oral opioid products have been designed in the same manner, including a hydrocodone product from Purdue. The FDA lets manufacturers state that such products are formulated with abuse-deterrent properties. But it hasn’t allowed claiming that a product actually reduces abuse.
The advisory committee meeting was called to review Purdue’s postmarketing studies with OxyContin, not because of overt efforts by Purdue to seek expanded claims.
The agency said, FDA recognizes that an ADF of a single product cannot solve the opioid addiction challenge or the opioid crisis. But they are asking the committees to discuss and provide their viewpoints on broader public health impacts- both positive and negative of OxyContin's reformulation in the complex and evolving landscape of opioid use, abuse, opioid addiction, and overdose.
FDA reviewers mentioned that both overall and non-oral abuse rates in the schedule II, opioids remain comparatively high even after OxyContin ADF was launched. This showed that, while the reformulation could have improved the safety of OxyContin with respect to non-oral abuse, ADF OxyContin is not quite safer than other marketed opioid analgesics with reference to abuse and associated risks.
The reformulated OxyContin is more tamper-resistant than the previous version as mentioned in the briefing document. Inspite of this it does not reduce the risk of the most common route of abuse -swallowing capsules or tablets.
While mentioning about the postmarketing studies, FDA staff wrote that it provides considerable, compelling evidence that reformulation decreased non-oral abuse of OxyContin in people who are entering or being assessed for treatment. Though it is not possible to quantify the size of this effect.
This reduction was found to have occurred predominantly among people assessed to have moderate to severe addiction.
Though they added, oral abuse of OxyContin was common in this population both before and after reformulation. This study doesn’t give any compelling evidence that the reformulation reduced overall OxyContin abuse, through any route in this population.
Substance use disorder and opioid addiction are major healthcare challenges faced by America.