What was the role of the Pentagon in approving an opiate in the United States? 1000 times more powerful than morphine

The opioid dependence crisis experienced in the United States did not prevent the authorities of this country from authorizing the entry into the market of a new drug of this type called Dsuvia ten times more powerful than fentanyl and a thousand times stronger than morphine.

The Food and Drug Administration (FDA) endorsed Dsuvia last Friday, although some Democratic senators and the chair of the FDA's Anesthetic and Analgesic Drugs Advisory Committee, Raeford Brown, had asked not to do so .

The excessive use of opiates has caused a serious crisis in this North American country, where more than 115 people die each day from an overdose, according to data from the Centers. for Disease Control and Prevention (CDC). These include painkillers, heroin and synthetic opiates such as fentanyl.

The opioid abuse has not only caused a health crisis, but also an economic crisis, in that it generates a "burden" of 78 500 million US dollars per year in medical care. CDC, estimates loss of productivity, drug treatment and court proceedings.

FDA Commissioner Scott Gottlieb admitted in a statement Friday that opioid addiction was a priority for his institution. But he also expressed the FDA's motives for allowing its marketing, the main one of them being its military application.

"Priority for the Pentagon"

Dsuvia is a "priority drug for the Pentagon", according to Gottlieb.

The US military was interested in this drug, not only for its effectiveness, but also for its mode of application.

It is composed of sufentanil, a substance that was previously administered intravenously or epidurally. But the novelty of Dsuvia is that it consists of a small pill placed under the tongue with a single-dose applicator.

"These unique characteristics in which the drug is stably administered make it perfectly adapted to particular circumstances, patients are not able to swallow oral medications and in which access to intravenous badgesics is not possible ", said Gottlieb.

" This includes possible uses on the battlefield ", where this product will fill a" unmet medical need ", which allowed the Ministry of Defense to "work closely" with the developers of Dsuvia, explained the Commissioner.

Gottlieb admitted that, in this case, "the military application of this new drug was taken in is cautious "and that the needs of the military sector and the involvement of Defense in the creation of Dsuvia were part of the debate held by the commission On October 12, the President of the FDA decided to app to find this drug by 10 votes against 3.

Deviating Use

Raeford Brown, Professor of Anesthesiology at the University of Kentucky. , believes that sufentanil is a medicine "extremely likely to be misused".

This was explained in a letter signed with experts from the Public Citizen lobby group in which he urged the FDA not to give Dsuvia the green light.

"It is a potent opioid with significant risks of respiratory depression, deviation (from its use), abuse and death."

"It is so powerful that those who abuse its intravenous version die often by injecting the first dose, "a situation he claims to have witnessed.

The expert predicts that even in small formats, in the months following his entry into the market, "we will find a diversion (of its use), abuse and death".

However, Gottlieb recalled in his statement that the European Medicines Agency In July, he approved the same drug, although he called Dzuveo.

He also stated that access to Dsuvia would be limited to "sanitary environments with certified medical supervision", such as hospitals or emergency centers; it can only be administered by health professionals and never for more than 72 hours.

Brown, however, baderted that the FDA "traditionally lacks the ability" to "apply controls" and that sublingual sufentanil "is a danger to public health in general."

"This will make our protection work Americans more difficult. "

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