Sunday, 18 November, 2018

FDA Approves Opioid Drug 1,000 Times Stronger than Morphine

FDA approves new opioid The FDA just approved an opioid painkiller 10 times more powerful than fentanyl
Steve Townsend | 08 November, 2018, 08:34

Experts and elected officials are lambasting the Food and Drug Administration for approving a new opioid that is 500 times stronger than heroin as the nation is in the grip of an addiction crisis.

Public Citizen described the drug as "five to 10 times more potent than fentanyl and 1,000 times more potent than morphine". Also, Dr. Palmer argues that risk for abuse is low because it must be administered-again, by a health care professional in a controlled medical center setting-under the tongue.

Although the FDA is committed to reducing the opioid crisis and despite their claims to work in the interest of addiction-free drugs, the latest opioid may go against everything that has been said.

The medication won't be available at pharmacies and shouldn't be used for more than 72 hours.

But public advocacy groups were quick to condemn the decision because they fear it will lead to more overdoses.

The drug is for very restricted use in operating rooms or on the battlefield. The FDA commissioner has also taken an unusual stance by saying that he wants more authority for the agency to consider similar drugs in the market which would make it easier for the agency to turn down applications for opioids in the future. But Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the committee, then took the rare step of publicly condemning that decision and urging the FDA to reject the drug. It would not be available in retail pharmacies.

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In a statement, FDA Commissioner Scott Gottlieb M.D. explained that the drug could be of good use in cases where the patient may not be able to swallow properly, and how the Department of Defense worked closely with the sponsor in the development of the drug, particularly because of its need to treat soldiers in the battlefield. Angotti noted that the drug will be subject to a Risk Evaluation and Mitigation Strategy program.

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. The numbers say it all: More people die in the U.S. each year from drug overdoses than from breast cancer. A spokeswoman said the company is not providing information on expected sales.

"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.

"It's a huge mistake", Wolfe said.

In one study, the pill provided about the same pain relief to patients as IV morphine.

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