FDA approval without testing

FDA Approves Opioid Drug That’s 1,000 Times Stronger Than Morphine


The U.S. Food and Drug Administration (FDA) has approved a new opioid drug that’s 1,000 times more powerful than morphine and ten times more powerful than Fentanyl.

The drug, called Dsuvia, comes in tablet form that’s administered under the tongue.

The FDA has been criticized for approving the drug at a time when the nation is battling increasing opioid deaths. Last year, 50,000 Americans died from opioid overdoses.

Dsuvia will be restricted to use in health care settings, such as emergency rooms, surgery centers and hospitals. But critics of the drug fear that the tablets will make their way to the streets, further fueling the opioid epidemic.

Last month, Massachusetts Senator Ed Markey urged the FDA not to approve the drug.

“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,” said Senator Markey.

Scott Gottlieb, FDA Commissioner, said in a statement that Dsuvia will be under “very tight restrictions.”  The medication, he said, will not be available for home use or at retail pharmacies.

Dsuvia, which will be manufactured by AcelRx Pharmaceuticals, will come in single-use packages and should not be used for more than 72 hours. Side effects of the drug include breathing problems, extreme fatigue, coma and death.

“Dsuvia is very different from most opioids,” says Dr. Pamela Palmer, Co-Founder and Chief Medical Officer at AcelRx Pharmaceuticals. “You will not find it in Walgreens or CVS.”

“There is currently no way available to rapidly treat your pain without sticking you with a needle,” Palmer explains. “If you broke your femur and are obese or elderly or on a blood thinner, that can be very painful with a lot of bruising. If you take a pill, you have to swallow it with water and wait for it to kick in, which could take up to an hour. Right now, that’s all that’s available. For the first time, we’ve developed a small tablet that goes under the tongue and dissolves in about six minutes.”

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