The drug dependency crisis in the United States did not prevent the authorities of this country from approving the entry of a new drug called Dsuvia, which is ten times stronger than fentanyl and 1000 times stronger than drugs. Morphine
The Food and Drug Administration (FDA) approved Duvia last Friday, despite the fact that some senators of the Democratic Party and president of the FDA's Committee for Anesthesia and Analgesic Drugs, Raeford Brovn, asked him not to do so.
Excessive use of opiates has caused a serious crisis in this North American nation, where more than 115 people die from overdoses every day, according to data from the Centers for Disease Control and Prevention (CDC for its acronym in English). This includes analgesics, heroin and synthetic opiates such as fentanyl.
Opioid abuse has not only caused the health crisis, but also the economic crisis, as it generates a "burden" of $ 78.5 billion per year in medical care, loss of productivity, drug treatment and judicial processes, according to the CDC.
FDA commissioner Scott Gottlieb acknowledged on Friday that opiate dependence is a priority for his institution. However, he also cited reasons for the FDA to allow his commercialization, and his main military application is the main issue.
"Priority for the Pentagon"
Duvia is "a priority drug for the Pentagon," says Gottlieb.
The US Army is interested in this drug not only because of its potential, but also because of its application.
It is made of sufentanil, a substance that has been administered intravenously or epidural to date. But the Duvija newspaper is that it consists of a small pill under the tongue with a single dose application.
"These unique characteristics in which the drug is applied in a stable manner makes it ideal for certain specific circumstances in which patients are not able to swallow oral medicines and where access to intravenous analgesics is not possible," said Gottlieb. .
"This includes possible use on the battlefield," where this product will meet the "inevitable medical need," something the Ministry of Defense "worked closely with" the developers of Dsuvia, the commissioner explained.
Gottlieb acknowledged that in this case "the military application of this new medicine was carefully considered" and that both the needs of the military sector and the involvement of the defense in the creation of Dzvija were part of a discussion held by the FDA Advisory Board, which decided on October 12 recommend that this medicine be approved with 10 votes for 3 against.
Raeford Braun, a professor of anesthesiology at the University of Kentucky, believes that sulphantanil is a medicine that is "extremely likely diversified".
This was explained in a letter signed with experts of the group for a public civic group in which he urged the FDA not to give Duvija the green light.
"It is a powerful opioid with a significant risk of respiratory depression, redirection (its use), abuse and death."
"It's so powerful that those who misuse their intravenous version often die by injecting the first dose," the situation he claimed to be a witness.
The expert predicted that, even in small forms, "redirection (use), abuse and death" will be found in the months after entering the market.
Gottlieb, however, recalled in his statement that the European Agency for Treatment also approved the same drug in July, although it is the name of Dzhuveo.
In addition, he stated that Duvia's approach would be limited to "sanitary environments with certified medical supervision", such as hospitals or emergency centers; It can only be medical experts and never more than 72 hours.
However, Braun claimed that the FDA "historically lacks the ability" to "control" and that sublingual sufentanil "poses a threat to public health."
"It will do our job to protect Americans with difficulty," he said.