The crisis of opiate dependence in the United States has not prevented the authorities of this country from authorizing the entry into the market of a new drug of this type called Dsuvia, which is ten times more potent than fentanyl and 1000 times stronger than drug. Morphine
The Food and Drug Administration (FDA) gave Dsuvia approval last Friday, despite the fact that some Democrat Senators and FDA Chairman Raeford Brown had asked him not to do so.
Excessive use of opiates has caused a serious crisis in this North American nation, where over 115 people die every day because of overdose from them , according to data from the Centers for Disease Control and Prevention (CDC). These include analgesics, heroin and synthetic opiates such as fentanyl.
Opioid abuse has not only provoked a health crisis but also a financial crisis as it creates a "cargo" of 78,500 million US dollars a year healthcare, loss of productivity, drug treatment, and court proceedings, according to the CDC.
FDA Commissioner Scott Gottlieb admitted Friday a statement that opiate addiction is a priority for his institution. However, it also expressed the reasons why the FDA allowed its commercialization as it was the main one military implementation .
"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 because of its strength but also because of it application form .
It is made of sufentanil, a substance that has so far been administered intravenously or epidermally. But the innovation of Dsuvia is that it consists of a small pill placed under the tongue with a simple dose dispenser.
"These unique features, in which the drug is administered consistently, make it ideal for some special circumstances patients are unable to swallow medicines from the mouth and in which access to intravenous analgesics is not possible "said Gottlieb.
"This includes possible uses in the battlefield," where this product would fill an "unmet medical need", which caused the The Ministry of Defense "will work closely" with Dsuvia developers, as explained by the Commissioner.
Gottlieb admitted that in this case "the military application of this new drug was carefully taken into account" and that both the needs of the military and defense involvement in the creation of Dsuvia were part of the discussion conducted by the FDA , which on 12 October decided to inform that this medicinal product was approved with 10 votes in favor against 3 against.
Rawford Brown, a professor of anesthesiology at Kentucky University, believes sufentanil is a medicine "extremely likely to be diverted."
This is explained in a letter signed with experts from Citizen's Pressure Group in which he urged the FDA not to give Dsuvia the green light.
"It is a powerful opioid with significant risks of respiratory depression, misuse, abuse and death."
"It's so powerful that those who abuse their intravenous delivery often die by infusing the first dose," a situation that claimed to be a witness.
The expert predicted that, even in small forms, in the months following his entry into the market, "we will find deviation (from use), abuse and death "
However, Gottlieb recalled in his statement that the European Medicines Agency approved the same drug in July, although there is the name of Dzuveo.
In addition, he said access to Dsuvia would be limited to "certified health care environments" such as hospitals or emergency centers. It can only be given by professionals in the medical field and never for more than 72 hours.
Brown, however, claimed that the FDA "has a historical lack of capacity" to "impose controls" and that sublingual sufentanil "endangers general public health."
"It will make our job to protect Americans more difficult," he said.
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