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(CNN) – Despite the opioid crisis in the country, the US Food and Drug Administration on Friday approved a new opioid drug five to ten times stronger than fentanyl.
Dsuvia, manufactured by AcelRx Pharmaceuticals Inc., is a single-dose pre-filled applicator tablet to be administered under the tongue by healthcare providers to patients in settings such as hospitals, surgical centers and emergency rooms, according to the company .
FDA Commissioner Dr. Scott Gottlieb quickly defended the approval in a statement Friday: "The agency is taking further steps to more actively deal with this crisis, while paying special attention to needs of patients and physicians who manage the pain. "
In April, Gottlieb told CNN's medical correspondent, Dr. Sanjay Gupta, that opioids were the biggest crisis the country faces, a crisis fueled by over-prescription. The numbers say it all: In the United States, more people die each year from drug overdoses than breast cancer.
After Dsuvia's approval, Gottlieb acknowledged that opioids are a single class of drugs. "I recognize that the debate goes beyond the characteristics of this particular product or the steps we take to mitigate the risks of this drug and preserve its differentiated benefits.We will not impinge on what I believe to be the true underlying source of dissatisfaction among critics of this approval – the question of whether America needs another powerful opioid in a crisis of dependency, "he said.
But the criticisms were fast. "The US Food and Drug Administration (FDA) is recklessly and needlessly endangering people by endorsing an extremely potent opioid," said Public Citizen's advocacy group, in response to this approval. The group noted that Dsuvia is five to ten times more potent than fentanyl and a thousand times more potent than morphine.
"It is certain that Dsuvia will worsen the epidemic of opioids and will kill people unnecessarily," said Dr. Sidney Wolfe, founder and senior advisor of Public Citizen's health research group.
"DSUVIA will not be available in retail pharmacies or outpatient .. DSUVIA will only be distributed to certified health care facilities in the program Assessment and Mitigation Strategy (REMS) ) of DSUVIA after certification by an authorized representative that health facilities will comply with DSUVIA's distribution and use restrictions, "said AcelRx.
According to the FDA, the drug should not be used for more than 72 hours and contains the same warnings as those required for all opioids regarding the risk of abuse and abuse that can result in dependence and death by overdose.
"Due to the risks of opioid addiction, abuse and misuse, Dsuvia should also be reserved for patients for whom alternative pain treatment options have not been tolerated or should not be tolerated. tolerated adequate analgesia, or where these alternatives should not provide adequate analgesia, "according to a statement by Gottlieb about the approval of the drug.
The statement highlighted the benefits of drugs for wounded soldiers on the battlefield. He notes that the Department of Defense was involved in its development and that it was a priority for the Pentagon because it "meets an unmet need".
The same drug, called sufentanil, is already available in IV. In its newly approved form, it is an option for patients with acute pain who can not receive IV infusion or are unable to swallow a pill. Dsuvia was approved by the European Medicines Agency in June under the name of Dzuveo.
Dsuvia was rejected by an FDA advisory committee in 2017 because the committee wanted more data. AcelRx returned to the committee this year and on October 12, the drug was recommended for approval. It should be available in the first quarter of next year.
"As a non-invasive single-dose drug with a rapid reduction in the intensity of pain, DSUVIA represents an important alternative for healthcare providers, which offers patients acute pain treatment," said the Dr. David Leiman, clinical assistant in surgery at the University of Texas at Houston, said in a statement from AcelRx. Leiman was a researcher in an AcelRx study on Dsuvia in post-surgical patients.
The-CNN-Wire
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