The Food and Drug Administration (FDA) is taking heat for approving a powerful, fast-acting opioid. Mine.Gottlieb said military use of the drug was "carefully considered in this case" as the FDA wants to "make sure our soldiers have access to treatments that meet the unique needs of the battlefield."More: Drugs kill more Americans than guns, cars and AIDS".
Dsuvia comes as a tablet in an applicator that health care providers administer under the tongue.
The drug is called Dsuvia, and FDA commissioner Scott Gottlieb, MD, addressed the timing in a statement released late last week. "The crisis of opioid addiction is an issue of great concern for our nation", he said. The medication, which comes in a single-use package, also should not be used for more than 72 hours.
Supporters of the drug also argue that even though sufentanil is known to be very potent, the effective dose of Dsuvia is a tiny, premeasured 30 mcg.
Gottlieb said the drug will carry a boxed warning and won't be available at drugstores for patients to take home. It is restricted to being used in certified medically supervised health care settings like hospitals, surgical centers, and emergency departments. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001. 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.
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"DSUVIA will not be available in retail pharmacies or for outpatient use".
In a statement issued Friday, the group contended that, "if approved, Dsuvia will be abused and start killing people as soon as it hits the market".
Sidney Wolfe of Public Citizen's Health Research Group, a consumer group, called Gottlieb's statement "empty rhetoric" and said the agency missed a big opportunity when it approved the pill. Angotti noted that the drug will be subject to a Risk Evaluation and Mitigation Strategy program. The numbers say it all: More people die in the USA each year from drug overdoses than from breast cancer. Company executives said they expect to launch Dsuvia in the first quarter of 2019.
U.S. Sen. Edward J. Markey sharply criticized an FDA advisory committee's vote to approve Dsuvia last month. According to Gottlieb, "This opioid formulation, along with Dsuvia's unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation's soldiers on the battlefield".
"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.