The crisis of opioid addiction in the United States has not prevented the authorities in that country from approving the market entry of a new drug of this type called Dsuvia, which is ten times stronger than fentanyl and 1,000 times stronger than the drug. morphine.
The Food and Drug Administration (FDA) approved Dsuvia last Friday, despite the fact that some Democratic senators and chair of the FDA's Anesthetic and Analgesic Medicines Committee, Raeford Brown, have asked not to do so.
Excessive use of opioids has caused a severe crisis in this nation in North America, where more than 115 people die each day because of their overdose, according to the Center for Disease Control and Prevention (CDC for its English acronym ). These include analgesics, heroin and synthetic opiates such as fentanyl.
Opium abuse has not only provoked a health crisis but also an economic crisis because it generates a "burden" of $ 78.5 billion each year in healthcare, productivity loss, drug treatment and lawsuits, according to the CDC.
FDA commissioner Scott Gottlieb admitted on Friday that opiate addiction is a priority for his institution. But he also stated the reasons for the FDA to allow its commercialization, the main being its military application.
"Priority for the Pentagon"
Dsuvia is a "priority drug for the Pentagon," according to Gottlieb.
American militants were interested in this drug not only because of its potency but also because of its application.
It is produced from sufentanil, a substance that has so far 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 features in which the drug is administered in a stable way make it ideal for certain special circumstances in which patients are unable to swallow oral medications and where access to intravenous analgesics is not possible, "said Gottlieb. .
"This includes possible uses on the battlefield," where this product will fill an "unsatisfied medical need," which has made the Department of Defense "work closely" with Dsuvia developers, the commissioner explained.
Gottlieb acknowledged that in this case "the military application of this new drug was carefully considered" and that both the needs of the military sector and the involvement of Defense in the creation of Dsuvia were part of the FDA's consultative committee, who, on October 12, decided to advise that this drug be approved with 10 votes against 3 against.
Raeford Brown, professor of anesthesia at the University of Kentucky, believes sufentanil is a "highly susceptible to hijacking" drug.
This was explained in a letter signed with experts from the Citizen Citizen pressure group, asking the FDA not to give Dsuvia green light.
"It is a powerful opioid, with significant risks of respiratory depression, misuse (abuse), abuse and death."
"It's so powerful that people who abuse their intravenous version often die by injecting the first dose," a situation he claims to have witnessed.
The expert predicted that, even in small formats, in the months following his introduction to the market "we will find diversion, abuse and death."
Gottlieb, however, recalled in his statement that the European Medicines Agency also approved the same drug in July, although there is the name of Dzuveo.
In addition, he stated that access to Dsuvia will be limited to "certified health care environments" such as hospitals or emergency centers; This can only be managed by medical professionals and no more than 72 hours.
Brown, however, argued that the FDA "has no historical ability" to "impose control" and that sublingual sufentanil "poses a threat to general public health."
"It will make our work to protect Americans more difficult," he said.