FDA Approves Use of Potent New Painkiller, Dsuvia

Already dubbed fentanyl sticks, a new painkiller tablet that is 1,000 times more potent than morphine and 10 times stronger than fentanyl was approved by the FDA last Friday as an alternative to IV painkillers that are used in hospitals. It is a new take of the drug sufentanil, a 10-times more powerful version of fentanyl.

Known as Dsuvia, the use of the drug will be limited to health care settings such as hospitals, surgery centers and emergency rooms. However, critics worry the opioid will fuel an already very deadly and dangerous opioid epidemic.

In lieu of the approval the DEA also released its own report on the cause of most overdose deaths since 2001. Their report said that prescription drugs were responsible.

Democratic Senator Ed Markey of Massachusetts urged the FDA not to approve Dsuvia last month saying “an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill.”

To that, the FDA responded with a statement that “very tight restrictions” will be placed on Dsuvia. They also mentioned that the drug would not be available at retail pharmacies or for any home use at all. The medication, which comes in single dose packages, also should not be used for more than 72 hours. The medicine comes in a tablet that can dissolve under the tongue. Side effects, of course include extreme tiredness, pain relief, breathing problems, coma and death.

The FDA also mentioned that the drug would be for military use so “soldiers have access to treatments that meet the unique needs of the battlefield.”

But the military already has pain medications that can be administered under the tongue like Dsuvia, Andrew Kolodny, head of the Opioid Policy Research Collaborative at Brandeis University, told STAT News. “There is absolutely no need for this product…. Claiming we need it on the market to help soldiers on the battlefield is ridiculous.”

Critics say there is no reason to believe the FDA’s safety measures will really prevent abuse of this drug by medical professionals or anyone else who manages to get their hands on it. “Lack of historical ability of the FDA to enforce controls, the pharmacologic potency of the drug, and the ease with which this drug will be diverted are some of the reasons that I would never consider this product for marketing in the U.S.,” wrote Raeford Brown, professor of Anesthesiology and Pediatrics at the University of Kentucky.

From 1999 to 2016, more than 630,000 people in the United States died from a drug overdose; over half of those deaths involved opioid medication, according to the Centers for Disease Control. Since 2013, the CDC has noticed a considerable rise in the number of people overdosing on synthetic opioids like fentanyl. On average, 115 Americans die every day from an opioid overdose.

Dsuvia will be available early 2019.