[ad_1]
The US-based opiate addiction crisis does not prevent the authorities in this country from approving the entry of this new type of drug, Dsuvia, which is ten times as strong as fentanyl and 1000 times stronger than that drug. Morphine
The Food and Drug Administration (FDA) gave Dsuvia approval last Friday, despite the fact that some Democrats' senators and Raeford Brown, Chairman of the FDA Committee's Committee on Anesthetic and Pain Relief, did not ask him to do so.
Excessive use of opiates has led to a serious crisis in this North American country, where more than 115 people die every day from overdose, according to data from the Centers for Disease Control and Prevention (CDC for its acronym in English). These are analgesics, heroin and synthetic opiates such as fentanyl.
The incidence of opioids has caused not only a health crisis but also an economic crisis, as it causes a $ 78.5 billion annual burden in medical care, loss of productivity, drug treatment and legal proceedings.
FDA Commissioner Scott Gottlieb on Friday issued a statement that opiate addiction is a priority for his institution. But he also pointed out the reasons for the FDA to allow their commercialization, and the main thing is its military use.
Pentagon Priority
According to Gotlby, "Dsuvia" is a "priority drug in the Pentagon".
The novelty of Dsuvia is that it is given orally via a tablet under the tongue with the applicator.
US military drugs were interested in this medicine, not only because of its effects, but also because of its use.
It is made of sufentanil, a substance previously injected intravenously or epidural. But the novelty of Dsuvia is that it consists of a small, sublingual tablet with a single-dose applicator.
"These unique properties of the medicine are stable, makes it ideal for certain specific conditions in which patients are unable to swallow the thyroid gland and the availability of intravenous analgesics is not possible," said Gottlieb. .
"It also includes potential uses in the battlefield," in which this product fills "unmet medical needs", which gave the Department of Defense "close cooperation" with the developers of Dsuvia, explained the Commissioner.
Gottlieb acknowledged that "the military use of these new medicines was carefully considered" in the present case, and that both the military sector's involvement and the involvement of the defense in the development of Dsuvia were part of the FDA's consultation committee, which on October 12 decided to recommend that the medicine be approved by 10 votes in favor , against 3 against.
Unused use
Raeford Brown, an associate professor of anesthesia at the University of Kentucky, says that sufentanil is a drug that is "highly unlikely to be diverted."
To date, sufentanil was only administered intravenously and epidural.
This was explained in a letter signed with experts from the Society's Pressure Group, in which he urged the FDA not to grant Dsuvia a green light.
"It is a potent opioid with a significant risk of respiratory depression, abnormal (abuse), abuse and death."
"It's so powerful that those who abuse 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 formats, months after entering the market, we will find a diversion (its use), abuse and death.
However, Gottlieb recalled in his statement that the European Medicines Agency approved the same medication in July, although it is Dzuva.
He further stated that access to Dsuvia would be restricted to "sanitary environments with certified medical supervision" such as hospitals or emergency centers; It can only be used by medical professionals and never for more than 72 hours.
Braun, however, continued to argue that the FDA "lacked the capacity" to achieve "control" and that subfocus sufentanil "poses a threat to public health."
"It will make our job harder to protect the Americans," he said.
[ad_2]
Source link
