Sufentanil is currently used intravenously in operating rooms in tightly-controlled circumstances.
The chair of an FDA advisory panel is speaking out against the approval of a powerful new opioid that is even stronger than fentanyl, but despite his public stances it appears likely that the FDA will approve the drug.
“Opioids are substantially different than almost any other classification of drugs in that they carry with them the risks of tolerance, addiction, and death, and what we’ve been trying to get the FDA to come to grips with is that this class of drugs needs to be treated differently,” Raeford Brown, Jr., MD, chair of the Anesthetic and Analgesic Drug Products Advisory Committee and professor at the University of Kentucky told MedPage Today. “Some of the methodology they use to manage other drug classes are perhaps not reasonable with this.”
The drug in question is DSUVIA, a form of sufentanil, a synthetic opioid that is 500 times more powerful than morphine. Sufentanil is currently used intravenously in operating rooms in tightly-controlled circumstances, but DSUVIA would make it available in a tablet that is administered under the tongue.
On Oct. 12, the FDA’s advising committee voted 10-3 to allow the drug to go to market.
However, Brown said that many committee members — himself included — were absent for that vote because they were attending the American Society of Anesthesiologists conference.
“That’s one of the reasons I felt that I needed to speak up, because people that are regulating this drug need to be very thoughtful about the public health in this particular circumstance,” he said.
The drug would be approved with a Risk Evaluation and Mitigation Strategy (REMS) program, but Brown said that is not enough of a safeguard.
“There’s no indication whatsoever that any of the REMS programs for opioids have been effective in improving the safety,” he said.
Brown is so against the approval of DSUVIA that he penned an open letter to the FDA, saying that sufentanil has “substantial risks of respiratory depression, diversion, abuse, and death,” and that its benefits do not outweigh these risks.
“It is my observation that once the FDA approves an opioid compound, there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population relative to its benefit to the public health,” he wrote. “Briefly stated, for all of the opioids that have been marketed in the last 10 years, there has not been sufficient demonstration of safety, nor has there been post-marketing assessment of who is taking the drug, how often prescribing is inappropriate, and whether there was ever a reason to risk the health of the general population by having one more opioid on the market.”
Further information on the approval of DSUVIA is expected in early November.
