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FDA weighs role of high-dose opioids as two-day expert meeting begins

  • The Food and Drug Administration on Tuesday convened a public meeting to discuss the value and risks of strong doses of opioids.
  • Over the course of two days, members from two FDA advisory committees will hear from experts and the public on the appropriate role of prescribing opioids with high daily doses or high dosage strengths, weighing clinical utility against the potential risk of keeping such products available. 
  • Ultimately, the conversation could guide the agency on whether or not to take additional regulatory action on reducing the use of these types of opioids. The public meeting started Tuesday and will run through Wednesday at the FDA’s campus in Silver Spring, Maryland.

Opioid drugmakers face mounting legal risks, and recent court deals have brought new financial penalties. 

On Monday, Insys Therapeutics filed for bankruptcy protection, just days after reaching a $225 million settlement with the Justice Department and a month after founder John Kapoor and four former executives were convicted of bribing doctors to boost sales for Insys’ opioid spray.

Weeks ago, meanwhile, Teva agreed to pay $85 million to settle a lawsuit with the state of Oklahoma over allegations of “false and deceptive marketing campaigns” to sell its opioid products. Oklahoma’s lawsuit is also targeting Johnson & Johnson and Purdue Pharma.

The two-day meeting convened by the FDA could serve as a starting point for further action on the regulatory side.

The agency has sought to curb the crisis through warnings, changes to prescribing guidelines and approval of opioid overdose treatments. Still, it’s faced criticism for not acting more strongly, particularly when it comes to approving new opioids.

Last November, the FDA cleared AcelRx Pharmaceuticals’ Dsuvia (sufentanil), an opioid that’s roughly 1,000 times more potent than morphine. While then-agency chief Scott Gottlieb defended the decision, some public health voices, including the chairman of the FDA advisory committee that reviewed Dsuvia’s application, have rebuked the regulator.

Briefing documents prepared by FDA staff for this week’s meeting outlined the basis for its re-evaluation of the role played by high-dose opioids. Any action would have to balance two public health goals of reducing opioid misuse and addiction while making products available to meet patients’ medical needs, FDA staff wrote. 

Through a review of post-marketing and prescription data, the FDA found the number of prescriptions for higher-dose products “decreased at a faster rate” than for lower-dose opioids from 2013 to 2018. In polling multiple healthcare consortiums, the FDA also determined these high-strength drugs were typically used to treat patients with cancer or for end-of-life care.

Most patients starting on these high-strength opioids had claims of back pain, nervous system conditions such as chronic pain syndrome or neuropathy, or arthritis, according to the agency’s review of one aggregate claims database.

And while the briefing documents for the meeting detailed some of the potential risks, staffers stopped short of conclusively linking dosage strength to addiction.

“However, due to the limitations of healthcare data, including the difficult establishing temporal relationships, it remains unclear whether the higher dose plays a causal role in the development of opioid addiction,” the document states.