FDA Approves New Opioid Despite Concerns Over Abuse And Misuse

Faith Castro
November 7, 2018

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".

"We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval-the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", Gottlieb's wrote. 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 point out that this comes amid an opioid epidemic in the United States - which led to more than 72,000 deaths in 2017 alone. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

At the same time, FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market. On October 12-so, not that long ago-AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee. Approval of the drug was highly criticized; Raeford Brown, MD, chair of the FDA's Anesthetic and Analgesic Drug Products Committee, urged the FDA not to approve Dsuvia.

Another criticism to be voiced is that Dsuvia is unnecessary: a drug that will not really add any benefit to an already saturated-and very unstable-opioid market. It would not be available in retail pharmacies.

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Can the drug be prevented from being abused and misused? The opioid in question is a highly potent, and risky drug that has more risks than benefits in health-care. The medication is called DSUVIA; it is a single-dose 30 mcg sublingual tablet of sufentanil.

There's more on pain control at the American Society of Anesthesiologists.

"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 related to battlefield wounds". She said caregivers can make these mistakes as they calculate the amount of clear liquid painkillers such as morphine to administer intravenously.

Including brand name and generic drugs, there are almost 400 opioids now on the market.

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