Friday, 16 November, 2018

FDA Approves Powerful Opioid Pill as IV Painkiller Alternative

FDA approves new opioid The FDA just approved an opioid painkiller 10 times more powerful than fentanyl
Celia Hoffman | 07 November, 2018, 22:31

"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", he said. Others weren't convinced that the drug's benefits outweighed potential risks.

The Food and Drug Administration approved a powerful new opioid Friday for use in health care settings, rejecting criticism from some of its own advisers that it would inevitably be diverted to illicit use and cause more overdose deaths.

Dsuvia is a sublingual (meaning it is taken under the tongue) form of sufentanil (a synthetic opioid) that's delivered through a disposable, pre-filled, single-dose applicator, the FDA says.

Along with the approval, Commissioner Scott Gottlieb released a statement of more than 2,200 words explaining the decision as well as how the agency will consider future opioid applicants.

The New York Times: F.D.A.

Leading the dissent was Raeford Brown, the chairman of an FDA advisory committee that reviewed AcelRx Pharmaceuticals' Dsuvia last month and ultimately recommended its approval in a 10-3 vote.

The sublingual administration makes Dsuvia an option for patients with nothing by mouth (NPO) status and patients with hard IV access (obese, elderly, burn or needle-phobic patients), according to the statement.

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Kolodny called Dsuvia an "exceptionally dangerous" drug that is 10 times stronger than fentanyl, which is 50 times stronger than heroin.

The FDA has approved this new drug in the midst of a severe opioid epidemic in the country.

"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?"

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

But this wasn't an Federal Bureau of Investigation sting or DEA operation. As part of the program, the drug maker will monitor distribution and audit wholesalers' data, evaluate proper use in the healthcare setting, and monitor for diversion or abuse and decertify any healthcare setting that is noncompliant. The OCI, it turns out, is staffed by 300 gun-toting officers, all of them employees of the same bureaucracy that issues food recall notices and verifies that medicines are safe and effective.

According to the FDA's statement, the drug was designed for military use, and while no one wants soldiers to suffer, some may argue that in the war against opioid-related overdoses, there are plenty of battlefields right here at home-with more than 115 people dying after overdosing on opioids every single day in the United States.

The approval comes just a bit more than a year after President Donald Trump declared the opioid crisis a public health emergency.

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