An FDA advisory panel will on whether or not Purdue Pharma's abuse-deterrent formulation (ADF) of oxycodone (OxyContin) "meaningfully reduced" opioid-related overdoses and deaths since it reached market 10 years ago.
The FDA's Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products advisory committees to review findings from four postmarketing studies conducted by Purdue investigating whether or not the ADF OxyContin lowered risk of adverse outcomes associated with opioid abuse.
After hearing presentations from the FDA, the manufacturer, and the public, panel members will discuss and vote on whether the ADF OxyContin -- introduced in 2010 as tablets made to be hard to crush or dissolve, replacing a previous version that was easy to snort or inject for a quick high -- reduced abuse or had any unintended adverse consequences, and its overall impact on public health.
Agency staff found that reformulated OxyContin may have decreased abuse by "non-oral routes," according to an 888-page prepared for panel members. But they found little good evidence that the product made a substantial dent in overall abuse.
A number of other oral opioid products have been designed similarly, including a hydrocodone product from Purdue. The FDA allows manufacturers to state that such products are formulated with abuse-deterrent properties, but it hasn't yet let any claim that a product actually reduces abuse. Notably, the advisory committee meeting this week was called merely to review Purdue's postmarketing studies with OxyContin, not because of overt efforts by Purdue to seek expanded claims.
"While FDA recognizes that an ADF of a single product cannot solve the opioid crisis, we are asking the committees to discuss and provide their viewpoints on broader public health impacts, both positive and negative, of OxyContin's reformulation within the complex and evolving landscape of opioid use, abuse, addiction, and overdose," the agency stated.
FDA reviewers wrote that both overall and non-oral abuse rates among schedule II opioids remained relatively high even after OxyContin ADF was launched, "indicating that, while the reformulation may have improved the safety of OxyContin with respect to non-oral abuse, ADF OxyContin is not necessarily safer than other marketed opioid analgesics with respect to abuse and associated risks."
The briefing document agrees that reformulated OxyContin is more tamper-resistant than the previous version. However, this does not reduce risk of the most common route of abuse -- swallowing capsules or tablets.
Writing about one of the postmarketing studies, for example, FDA staff wrote that it "provides reasonably compelling evidence that reformulation decreased non-oral abuse of OxyContin in people who are entering or being assessed for treatment, although it is not possible to quantify the size of this effect. This reduction appears to have occurred predominantly among people assessed to have moderate to severe addiction."
But, they added, "[o]ral abuse of OxyContin was common in this population both before and after reformulation, and this study did not provide compelling evidence that the reformulation reduced overall OxyContin abuse (via any route) in this population."
An FDA advisory committee meeting to evaluate reformulated OxyContin was originally slated to take place in July 2015. At that time, Purdue was asking for new labeling to describe the real-world impact of the ADF product on outcomes such as opioid overdose and death.
But one day before the FDA was scheduled to release its technical assessment of the postmarketing study findings, Purdue withdrew the application. The staff evaluation was not released and the committee meeting was cancelled.