The opiate addiction crisis in the United States has not prevented the country's authorities from granting entry to the market of a new type called Dsuvia that is ten times stronger than fentanyl and 1000 times stronger than drugs. morphine.
The Food and Drug Administration (FDA) gave Dsuvat's approval last Friday despite the fact that some Democratic senators and chairman of the FDA's Anesthetic and Analgesic Board Raeford Brown had asked him not to do so.
Excessive use of opiates has caused a serious crisis in the North American country, where more than 115 people die from overdoses, according to data from the Center for Disease Control and Prevention (CDC) in the English language acronym. 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 $ 78.5 billion annual "burden" of medical care, loss of productivity, drug treatment, and judicial proceedings, according to the CDC.
FDA Commissioner Scott Gottlieb acknowledged on Friday in a statement that dependence on opiate priority for his institution. But he also stated the reasons for the FDA to allow commercialization, and its main 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 power, but also for its application.
It is made of sufentanil, a substance that has been administered intravenously or epidurally so far. But the novelty of Dsuvia is that it consists of a small tablet placed under the tongue with a single dosage application.
"These unique features in which the drug is applied in a stable manner makes it ideal for specific circumstances in which patients are unable to swallow oral drugs and are unable to access intravenous analgesics," said Gottlieb. .
"This includes possible use on the battlefield," where this product will meet "unsatisfied medical needs," which has led the Ministry of Defense to "closely cooperate" with developers Dsuvia, the Commissioner explained.
Gottlieb admitted that in this case "military application of this new medicine was carefully taken into account" and that the needs of the military sector and the involvement of the Defense in the creation of Dzuwa were part of the discussion held by the FDA's advisory board, which on October 12 decided to advise this drug is approved with 10 votes versus 3 against.
Raeford Brown, a professor of anesthesiology at the University of Kentucky, believes that sufentanil is a medicine that is "highly likely to be redirected".
This is explained in a letter signed with experts from the Public Citizen Press Group, calling on the FDA not to give Green Light to Dwight.
"It's a powerful opioid with a high risk of respiratory depression, abuse, abuse, and death."
"It's so powerful that those who abuse their intravenous version often die by first dose injection," the situation he claimed to have testified.
The expert has predicted that, even in small format, in the months following his entry into the market, "we will find abuses, abuse and death".
Gottlieb, however, recalled in his statement that the European Medicines Agency also approved the same medicine in July, although it is called Dzuveo.
In addition, he stated that access to Dzuvi would be limited to "sanitary environments with certified medical supervision", such as hospitals or emergency centers; It can only be controlled by medical professionals and never more than 72 hours.
Brown, however, continued to argue that the FDA "historically has no ability" to "control" and that sublingual sufentanil "poses a threat to public health."
"It will do our job to protect Americans harder," he said.