FDA OKs Powerful new opioid despite criticism

By E.J. Mundell

HealthDay Reporter

FRIDAY 2 Nov. 2018 (HealthDay News) – Based on the recommendation of one of its main experts, the US Food and Drug Administration has approved an extremely powerful new opioid painkiller, Dsuvia, on Friday.

The drug is a 30-microgram pill that packs the same punch as 5 milligrams of intravenous morphine, according to the Washington Post. The small pill is packaged in a syringe-like applicator and would be used under the tongue for rapid absorption. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.

The drug is for very limited use in operating rooms or on the battlefield. Indeed, the potential use by soldiers was one reason why Dsuvia was approved, according to FDA Commissioner Dr. Scott Gottlieb.

"The FDA has given it a high priority to ensure that our soldiers have access to treatments that meet the unique needs of the battlefield even when intravenous administration is not possible for the treatment of acute pain," Gottlieb said in a statement. news release from a desk.

But the approval of Dsuvia comes in the midst of controversy, with an epidemic of opioid abuse that continues to destroy the United States. Experts are concerned that the supply of the drug will in one way or another go from doctors' practices and pharmacies to addicts.

An FDA advisory committee recommended Dsuvia's approval with a 10-3 vote last month. But the chairman of the committee took the very unusual move to make his opposition known at that time. Dr. Raeford Brown, 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, which is not in line with the agency's charter," Brown said in a statement Friday. "I will continue to hold the agency responsible for their response to the worst public health problem since the flu epidemic of 1918."

The consumer watchdog group Public Citizen has also strongly opposed the approval. In a Friday statement, the group stated that "Dsuvia, if approved, will be abused and kill people as soon as it comes on the market."


Public Citizen described the drug as "five to ten times more potent than fentanyl and 1000 times more potent than morphine."

But Gottlieb stressed Friday that his office has imposed very strict restrictions on Dsuvia.

"To remove concerns about the potential risks of Dsuvia, this product will have strong limitations on its use," Gottlieb said. "It can not be administered to patients for home use and should not be used for more than 72 hours and should only be given by a healthcare professional who uses a single-dose applicator.This means that it will not be available at pharmacies for patients to use. to take home. "

The drug is also for use only by patients who can not 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 US Drug Enforcement Administration reported that the number of deaths from opioid overdose in the United States last year reached a new record with 72,000 deaths-about 200 per day.

And even when his office gave the nod to Dsuvia, Gottlieb said that other steps would be taken to limit access to very powerful opioids.

"The agency is taking new steps to deal more actively with this crisis, while also carefully considering the needs of patients and doctors who manage pain," he said. Part of that effort may be a closer and more rigorous assessment of the need for new opioid formulations in the future, Gottlieb added.

"To this end, I asked the FDA's professional staff to evaluate a new framework for opioid analgesic approvals," he said. It is already clear that in the context of the opioid crisis "our evaluation of opioids is different from how we evaluate drugs in other therapeutic classes," noted Gottlieb.

As far as Dsuvia is concerned, even after approval: "the FDA will implement the [regulatory safeguards] associated with Dsuvia and compliance requirements, and we will work to quickly implement regulatory changes if problems arise, "Gottlieb said.

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SOURCES: November 2, 2018, press releases, Public Citizen and U.S. Food and Drug Administration;Washington Post

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