The recent FDA approval of a new fast acting opioid product has been met with concern and controversy, especially in light of the current opioid crisis and the availability of other alternatives. In October of last year, the FDA voted to approve sublingual sufentanil tablets, to be sold under the name Dsuvia. Sufentanil is also currently used for anesthesia and is chemically related to fentanyl, but is more potent. This drug offers the benefit of being a fast-acting medication, with an onset of about 15 minutes, and is given under the tongue, so is not invasive like an injectable pain medication. The medication is only approved for use in a healthcare setting that is certified under the Risk Evaluation and Mitigation Strategies (REMS) program for this drug. This program requires healthcare facilities that dispense the drug to be specially trained and certified in order to minimize the risk of overdose and abuse.
Even with the required safety and monitoring restrictions, there is concern that diversion and abuse may occur, as with any opioid product. Concerns about the safety of the drug were described in a letter from Dr. Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, who describes resuscitating people who die after being given one dose of IV sufentanil. This includes not only patients who were given the drug, but healthcare workers who abused it. Dr. Brown also raised concerns about the voting process, and suggested the FDA rigged the vote by not including the full Drug Safety and Risk Management Advisory (DSaRM) committee when the vote was taken.
While the drug may provide some advantages over currently available options, the approval comes during a time when people expect increased scrutiny of opioids, and the need for new products may not outweigh the risks of putting more opioids on the market.