FDA approves a powerful new opioid, rejecting criticism from advisers


But U.S. Sen. Edward J. Markey, D-Mass., sharply criticized that vote, saying Dsuvia is an opioid painkiller up to 10 times more powerful than fentanyl and 1,000 times more powerful than morphine.

But critics of the drug and its potency - it's 10 times stronger than fentanyl - are tired that such a pill could add to the country's already alarming opioid epidemic. "We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval - the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", Dr. Gottlieb said. The pill is placed under the tongue for quick absorption and has the same impact as five milligrams of intravenous morphine, reported The Washington Post. And it should only be administered by a health care provider using a single-dose applicator.

Critics blasted the agency for bringing a new opioid to market as the nation faces increasing opioid overdose deaths in what many call a crisis. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

Along with the approval, Commissioner Scott Gottlieb released a statement of more than 2,200 words explaining the decision as well as how the agency will consider future opioid applicants. "The U.S. Food and Drug Administration (FDA) is recklessly and needlessly endangering people by approving a super-strong opioid", a statement from the public advocacy group Public Citizen said in response to the approval.

The tiny pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield. The single-strength tablet and single-unit packaging are created to mitigate the possibility of dosing errors, misuse and diversion.

Health experts said the pill isn't needed and will only worsen the opioid epidemic.

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The medication won't be available at pharmacies and shouldn't be used for more than 72 hours. The numbers say it all: More people die in the USA each year from drug overdoses than from breast cancer.

According to Gottlieb, there are very tight limitations for the use of the drug.

"The FDA approval of Dsuvia is the culmination of almost 15 years of research to improve the standard of care for managing acute pain in medically supervised settings", Palmer said in a statement.

The FDA has approved a new sublingual formulation of sufentanil, Dsuvia, for the management of acute pain in adults in medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.

Including brand name and generic drugs, there are almost 400 opioids now on the market.