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giftedviz.com December 14, 2018


FDA OKs powerful opioid pill as alternative to IV painkiller

07 November 2018, 10:31 | Rodolfo Wallace

FDA OKs powerful opioid pill as alternative to IV painkiller

FDA OKs powerful opioid pill as alternative to IV painkiller

The decision has met a lot of criticism because the opioid is 5-10 times more potent than pharmaceutical fentanyl. 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. 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.

FDA Commissioner Scott Gottlieb announced approval of AcelRx Pharmaceuticals' painkiller Dsuvia Friday, an announcement that largely went under the public's radar, except for a swift denouncement by U.S. Sen. The objective, of course, was for the committee to determine the drug's overall safety and efficacy; and the FDA usually follows whatever guidance their committees provide.

"DSUVIA will not be available in retail pharmacies or for outpatient use. 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", Dr. Gottlieb said. Part of that effort may be a closer and more stringent assessment of the need for new opioid formulations going forward, Gottlieb added.

The statement noted the benefit the drug could have for soldiers injured on the battlefield.

But Dsuvia's approval comes amid controversy, with an epidemic of opioid abuse continuing to ravage the United States. 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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Drug overdose deaths hit the highest level ever recorded in the United States a year ago, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration.

"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.

"I am very disappointed with the decision of the agency to approve Dsuvia".

The medication is called DSUVIA; it is a single-dose 30 mcg sublingual tablet of sufentanil. On October 12-so, not that long ago-AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee.

Emalie Gainey, a spokeswoman for state Attorney General Maura Healey, said Healey has "serious concerns" about Dsuvia and "will be monitoring this closely".



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