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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.
An FDA advisory committee did recommend for approval of Dsuvia in a 10-3 vote last month. But the committee’s chair took the highly unusual move of voicing his opposition at that time. Dr. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, urged the FDA to reject the drug.
“I am very disappointed with the decision of the agency to approve Dsuvia. This action is inconsistent with the charter of the agency,” Brown said in a statement Friday. “I will continue to hold the agency accountable for their response to the worst public health problem since the 1918 influenza epidemic.”
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.”
But Gottlieb stressed Friday that his agency has placed very tight restrictions on Dsuvia.
“To address concerns about the potential risks associated with Dsuvia, this product will have strong limitations on its use,” Gottlieb said. “It can’t be dispensed to patients for home use and should not be used for more than 72 hours. And it should only be administered by a health care provider using a single-dose applicator. That means it won’t be available at retail pharmacies for patients to take home.”
The drug is also only for use by patients who cannot tolerate other painkillers, or for whom other painkillers have failed or are expected to fail.
The United States continues to struggle with the opioid abuse epidemic. On Friday, new statistics released by the U.S. Drug Enforcement Administration found the number of opioid overdose deaths in the United States reached a new record last year with 72,000 deaths — about 200 per day.
And even as his agency gave the nod to Dsuvia, Gottlieb said other steps are being taken to restrict access to highly potent opioids.
“The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain,” he said. Part of that effort may be a closer and more stringent assessment of the need for new opioid formulations going forward, Gottlieb added.
“To that end, I’ve asked the professional staff at the FDA to evaluate a new framework for opioid analgesic approvals,” he said. Already, it’s clear that in the context of the opioid crisis, “our evaluation of opioids is different than how we assess drugs in other therapeutic classes,” Gottlieb noted.
As for Dsuvia, even after approval, “the FDA will continue to carefully monitor the implementation of the [regulatory safeguards] associated with Dsuvia and compliance with its requirements, and we’ll work to quickly make regulatory adjustments if problems arise,” Gottlieb said.