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By E.J. Mundell
HealthDay Reporter
FRIDAY, Nov. 2, 2018 (HealthDay News) – The US Food and Drug Administration has decided Friday to rule against the recommendation of one of its leading experts, the Dsuvia, an extremely powerful painkiller.
The drug is a 30 microgram pill that has the same effect as 5 milligrams of intravenous morphine, according to the Washington Post. The tiny pill is packaged in a syringe-like applicator and would be used under the tongue for rapid absorption. Dsuvia (sufentanil) will be marketed by the Californian manufacturer AcelRX.
The drug is for very limited use in the operating rooms or on the battlefield. Indeed, his potential use by soldiers was one of the reasons Dsuvia was approved, according to FDA Commissioner Scott Gottlieb.
"The FDA is given as a priority to ensure that our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration does not occur. is not possible for the treatment of acute pain, "Gottlieb said in a press release.
But Dsuvia's approval comes amid a controversy, an epidemic of opioid abuse continuing to ravage the United States. Experts fear that drugs will pass from doctors' offices and pharmacies to drug addicts.
An advisory committee of the FDA recommended Dsuvia's approval at a 10-3 vote last month. But the chairman of the committee made the very unusual decision to express his opposition at that time. Dr. Raeford Brown, professor of anesthesiology and pediatrics at the University of Kentucky, urged the FDA to reject the drug.
"I am very disappointed with the decision of the agency to approve Dsuvia.This action is inconsistent with the charter of the agency," said Brown in a statement on Friday. "I will continue to hold the agency responsible for its response to the worst public health problem since the 1918 flu epidemic."
The consumer monitoring group, Public Citizen, is also strongly opposed to approval. In a statement released on Friday, the group claimed that "if approved, Dsuvia will be abused and start killing people as soon as he enters the market."
Continued
Public Citizen has described the drug as "five to ten times more potent than fentanyl and a thousand times more potent than morphine."
But Gottlieb said Friday that his agency imposed strict restrictions on Dsuvia.
"To address concerns about the potential risks associated with Dsuvia, this product will have severe limitations on its use," Gottlieb said. "It can not be distributed to patients for home use and should not be used for more than 72 hours, and should only be administered by a health care provider using a single dose applicator. it will not be available at retail pharmacies for patients to take home ".
The drug is also reserved for the use of patients who do not tolerate other painkillers or for whom other analgesics have failed or are likely to fail.
The United States continues to fight the epidemic of opioid abuse. On Friday, new statistics released by the US Drug Enforcement Administration revealed that the number of opioid overdose deaths in the US had hit a new record last year with 72,000 deaths – about 200 a day .
And even though his agency winked at Dsuvia, Gottlieb said other steps were being taken to restrict access to extremely potent opioids.
"The agency is taking new steps to tackle this crisis more actively, while paying particular attention to the needs of the patients and doctors who manage the pain," he said. Part of this effort could consist of a narrower and more rigorous assessment of the need for new opioid formulations in the future, added Gottlieb.
"To that end, I asked the FDA's professional staff to evaluate a new framework for the approval of opioid analgesics," he said. Already, it is clear that in the context of the opioid crisis, "our evaluation of opioids is different from the way we evaluate drugs in other therapeutic classes," noted Gottlieb.
As for Dsuvia, even after its approval, "the FDA will continue to monitor closely the implementation of the [regulatory safeguards] to Dsuvia and meet its requirements, and we will work to make regulatory adjustments quickly if problems arise, "said Gottlieb.
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