The crisis of opiate addiction that exists in the United States did not prevent the authorities of that country from approving the market entry of a new drug of this type called Dsuvia that is ten times more powerful than fentanyl and 1,000 times stronger than the drug. morfina.La Administration of Food and Drugs (FDA for its acronym in English) gave the go-ahead to Dsuvia last Friday, despite the fact that some Democratic senators and the own president of the Advisory Committee of Anesthetic and Analgesic Drugs of the FDA, Raeford Brown , had asked not to do it. The excessive use of opiates has caused a serious crisis in this North American nation, where every day more than 115 people die from overdose of them, according to the data of the Centers for Disease Control and Prevention ( CDC for its acronym in English). These include analgesics, heroin and synthetic opiates such as fentanyl. Opioid abuse has not only caused a health crisis but also an economic one, since it generates a "burden" of US $ 78,500 million each year in medical care, loss of productivity, drug treatment and judicial processes, the CDC estimates. FDA Commissioner Scott Gottlieb admitted in a statement on Friday that opiate addiction is a priority for his institution. But he also stated the reasons for the FDA to allow its commercialization, being the main one of them its military application. "Priority for the Pentagon"
Dsuvia is a "priority drug for the Pentagon," according to Gottlieb.
The novelty of Dsuvia is that it is administered orally through a pill that is placed under the tongue with an applicator.
The US military was interested in this medicine not only for its potency, but also for its form of application. It is made of sufentanil, a substance that until now was 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 medication is administered in a stable manner make it ideally suited for certain special circumstances in which patients are not able to swallow oral medications and in which access to intravenous analgesics is not possible, "said Gottlieb." This includes possible uses on the battlefield, "where this product will fill an" unmet medical need ", something that He made the Department of Defense "work closely" with the developers of Dsuvia, the commissioner explained. Gottlieb admitted that, in this case, "the military application of this new medicine was taken into account with care" and that both the needs of the military sector as the defense implication in the creation of Dsuvia were part of the debate maintained by the FDA advisory committee, that the past October 12 decided to advise that this medicine be approved with 10 votes in favor versus 3 against.
Raeford Brown, who is a professor of anesthesiology at the University of Kentucky, believes that sufentanil is a drug that is "extremely likely to be diverted."
Until now, sufentanil could only be given intravenously and epidurally.
This was explained in a letter signed with experts from the Public Citizen pressure group in which he urged the FDA not to give Dsuvia the green light. "It is a potent opioid with substantial risks of respiratory depression, deviation (from its use), abuse and death. "" It is so powerful that those who abuse their intravenous version often die when they inject the first dose, "a situation he claimed to have witnessed. The expert predicted that, even in small formats, in the months following his entry to the market, "we will find diversion (use), abuse and death." Gottlieb, however, recalled in his statement that the European Medicines Agency also approved in July the same medication, although there is the name of Dzuveo. In addition, he stated that access to Dsuvia will be restricted to "sanitary environments with certified medical supervision", such as hospitals or emergency centers; it can only be administered by medical professionals and never for more than 72 hours. Brown, however, went on to claim that the FDA "historically lacks the ability" to "enforce controls" and that sublingual sufentanil "poses a danger to general public health. "" It will make our job of protecting Americans more difficult, "he said.