US FDA Approves New-and Very Potent-Painkiller, Despite Warnings

FDA approves powerful opioid despite fears of more overdose deaths

The drug approved Friday is a 30-microgram pill form of sufentanil, a powerful, 34-year-old opioid commonly used after surgery and in emergency rooms.

The U.S. Food and Drug Administration approved a powerful new opioid medication on Friday, in spite of major concerns raised by health advocates that the drug's strength and design could prove harmful for patients and the public.

Democratic Senator Ed Markey of MA urged the FDA not to approve Dsuvia last month, saying "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". 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.

Critics are blasting the FDA for approving Dsuvia as the country faces increasing opioid overdose deaths. "It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a statement. The opioid in question is a highly potent, and risky drug that has more risks than benefits in health-care.

The statement noted the benefit the drug could have for soldiers injured on the battlefield. AcelRx Pharmaceticals, maker of the drug, explains that, in many care settings-including battlefield settings-patients may not have readily available access to intravenous (IV) treatments for pain, and intramuscular injections (currently the standard of care for battlefield patients) are not as effective as IV options at providing timely relief, and may not be effective in cases of severe trauma that involves hypovolemic shock.

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Brown, four U.S. Senators and the advocacy group Public Citizen have predicted that Dsuvia will be diverted to illicit use and cause more opioid overdose deaths. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine.

The pills contain sufentanil, a chemical cousin of the opioid fentanyl.

AcelRx Pharmaceuticals, in a statement, said the drug was long in the making.

"I am very disappointed with the decision of the agency to approve Dsuvia". 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. Company executives said they expect to launch Dsuvia in the first quarter of 2019.

"We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", AcelRx CEO Vince Angotti said in a statement.

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