Ruling against the recommendation of one of its chief experts, the U.S. Food and Drug Administration on Friday approved an extremely potent new opioid painkiller, Dsuvia.
The drug is a 30-microgram pill that packs the same punch as 5 milligrams of intravenous morphine, according to the Washington Post. The tiny pill comes packaged in a syringe-like applicator and would be used under the tongue for quick absorption. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.
The drug is for very restricted use in operating rooms or on the battlefield. Indeed, its potential use by soldiers was one reason Dsuvia was approved, according to FDA Commissioner Dr. Scott Gottlieb.
“The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain,” Gottlieb said in an agency news release.
But Dsuvia’s approval comes amid controversy, with an epidemic of opioid abuse continuing to ravage the United States. Experts worry that supplies of the drug will somehow make their way from doctors’ offices and pharmacies to addicts.
The consumer watchdog group Public Citizen has also come out strongly against approval. In a statement issued Friday, the group contended that, “if approved, Dsuvia will be abused and start killing people as soon as it hits the market.”
Public Citizen described the drug as “five to 10 times more potent than fentanyl and 1,000 times more potent than morphine.”