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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 make an impasse on what I believe to be the real source of underlying discontent among critics of this endorsement – the question of whether America needs another powerful opioid while she is in a crisis of dependence, "he said.
But the criticisms were fast. "The US Food and Drug Administration (FDA) is unwittingly and needlessly endangering people by endorsing an extremely potent opioid," Public Citizen Group said in response to the approval. The group noted that Dsuvia is five to ten times more potent than fentanyl and a thousand times more potent than morphine.
"There is no doubt that Dsuvia will worsen the opioid epidemic and kill people unnecessarily," said Dr. Sidney Wolfe, founder and senior advisor of the Public Citizen Public Health Research Group.
"DSUVIA will not be available in retail pharmacies or for outpatient use. DSUVIA will only be distributed to health care facilities certified in the REMS (Risk Assessment and Mitigation) Program after certification by an authorized representative certifying that health facilities will comply with the applicable dispensing and use restrictions. of DSUVIA, "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.
"Because of the risks of opioid addiction, abuse and abuse; Dsuvia should also be reserved for patients for whom alternative pain treatment options are not tolerated, or should not be, when existing treatment options have not provided analgesia. sufficient or that 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 Ministry of Defense participated 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 single-dose, non-invasive drug with a rapid reduction in pain intensity, DSUVIA represents an important alternative for healthcare providers, which provides patients with acute pain treatment," said 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.
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