Despite concerns and controversies, the U.S. Food and Drug Administration (FDA) just approved an opioid that’s said to be 10 times more powerful than fentanyl.
Can the drug be prevented from being abused and misused?
FDA Approves Dsuvia
In a controversial move, the FDA just approved Dsuvia, a sufentanil sublingual tablet that is delivered via a disposable, single-dose applicator. It is the tablet version of an opioid that’s currently marketed for intravenous delivery, and was also approved in Europe just last July under the brand name Dzuveo.
A month prior to the FDA’s approval, critics urged the agency not to approve the drug because of its potential to be abused and misused, especially amid the ongoing opioid crisis. Some of the criticisms state that the drug has no unique medical benefits, even with the claim that it will be used to help soldiers, as there is already a sublingual fentanyl being used in the battlefield.
Furthermore, others also noted that the drug could be easily diverted by medical personnel, despite risk mitigation plans, and with the restriction that it could only be used in certified medically supervised healthcare settings.
Limited Use
In a statement, FDA Commissioner Scott Gottlieb M.D. explained that the drug could be of good use in cases where the patient may not be able to swallow properly, and how the Department of Defense worked closely with the sponsor in the development of the drug, particularly because of its need to treat soldiers in the battlefield.
According to Gottlieb, there are very tight limitations for the use of the drug. For instance, it may not be administered at home, and can only be administered by a health care provider, which means that the drug will not be available at retail pharmacies. Further, the drug will be limited for use in patients whom other analgesics were not tolerated, or are not expected to be tolerated.
He states that it is through the restricted use that the drug could be prevented from being abused, misused, or even diverted.
“We owe it to Americans who want the FDA to do our part to help end one of the biggest addiction crises of modern times, while we carefully balance these grave risks against patient needs,” said Gottlieb.
Criticisms Acknowledged
That said, Gottlieb still acknowledged the concerns and criticisms over the approval, as well as how it opened a broader discussion about FDA policy about opioids.
"We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval — the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction," he said.
