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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 Democrat Senators and the chair of the FDA's Anesthetic and Analgesic Drugs Advisory Committee, Raeford Brown, had asked him not to make.
The excessive use of opiates caused a serious crisis in this American nation, where more than 115 people die each day of overdoses . according to data from 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, to the extent that they generate a "burden" of 78 500 million US dollars per year. in medical care, loss of productivity, drug treatment and prosecution, according to CDC estimates.
FDA Commissioner Scott Gottlieb admitted in a statement Friday that opioid addiction was a priority for your institution. But he also indicated the reasons why the FDA authorized its marketing, being the main one among them its military application .
"Pentagon Priority"
Dsuvia is a "priority drug for the Pentagon," according to Gottlieb.
The US military was interested in this drug, not only because of its effectiveness, but also because of its form of application .
It is composed of sufentanil, a substance until now It has been administered intravenously or epidurally. But the novelty of Dsuvia is that it consists of a small pill that is placed under the tongue with a single dose applicator.
"These unique characteristics in which the drug is stably administered make it perfectly adapted to certain special circumstances those who patients are not able to swallow oral drugs and in which ] does not have access to intravenous pain medication "said Gottlieb.
"This includes possible uses in the Battlefield", where this product will meet an "unmet medical need", which allowed the Department 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 has been carefully considered" and that the needs of the military and defense participation in the creation of Dsuv They were part of the debate held by the FDA Advisory Committee, which decided on October 12 that this drug be approved with 10 votes for and against 3.
Deviant Use
Raeford Brown, who is a professor of Anesthesiology at the University of Kentucky and believes that sufentanil is a medicine "extremely likely to be diverted".
He explained this in a letter signed with experts of the pressure group Public Citizen in which he urged The FDA should not give the green light to Dsuvia.
"It is a potent opioid with significant risks of respiratory depression, diversion (from its use), abuse and death."
"He is so powerful that those who abuse it intravenously, he often dies when injecting the first dose," a situation he claimed to have witnessed.
The expert had predicted that even in small formats, in the months following his entry into the market, "we will find detour (of its use), abuse and death ." [19659003] However, Gottlieb recalled in his statement that the European Medicines Agency had also approved the same drug in July, although it bears the name of Dzuveo
. that access to Dsuvia will 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 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, "he concluded.
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