FDA Approves DSUVIA Sublingual Synthetic Opioid Formulation & Delivery System
08 November, 2018, 08:35 | Author: Cecil Davis
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".
The FDA insists it is managing the opioid crisis and the new drug is needed by patients to manage pain. According to critics, the decision will only fuel the United States' drug crisis even further rather than improving it. The medication, which comes in a single-use package, also should not be used for more than 72 hours.
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. "To what extent should we evaluate each opioid exclusively on its own merits, and to what extent should we also consider.the epidemic of opioid misuse and abuse that's gripping our nation?"
Gottlieb said the drug will carry a boxed warning and won't be available at drugstores for patients to take home. FDA has restricted its use to certified medically-supervised health care settings only, such as hospitals, surgical centers, and emergency departments, and for administration by a health care professional.
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.
"DSUVIA will not be available in retail pharmacies or for outpatient use".
The Food and Drug Administration on Friday approved a new form of an extremely potent opioid to manage acute pain in adults, weeks after the chairman of the advisory committee that reviewed it asked the agency to reject it on grounds that it would likely be abused.
"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Sidney Wolfe, founder of Public Citizen's Health Research Group, said in a statement.
An FDA advisory committee recommended approval of the new drug in a 10-3 vote on October 12. As such, "We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", said AcelRx's CEO, Vince Angotti, in a statement. The FDA endorsed Dsuvia, which can be applied once under the tongue and benefit soldiers on the battlefield where IVs can be impractical. "This drug just will work a lot more than morphine - it's 1,000 times stronger", she says. A spokeswoman said the company is not providing information on expected sales. She said caregivers can make these mistakes as they calculate the amount of clear liquid painkillers such as morphine to administer intravenously. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.
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