In a statement, FDA Commissioner Scott Gottlieb, MD, sought to deflect criticism of the approval, saying that, "Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that's available to patients and providers".
Despite the ongoing opioid crisis plaguing the nation, the US Food and Drug Administration on Friday approved a new opioid medication five to 10 times more powerful than fentanyl.
But critics of the drug and its potency - it's 10 times stronger than fentanyl - are tired that such a pill could add to the country's already alarming opioid epidemic. The drug is called Dsuvia, which is a tablet version of an opioid marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator.
Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis. "It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a statement.
As the worst drug crisis in USA history has accelerated, agency critics and some public officials have clamored for that holistic approach to narcotic painkillers, instead of the FDA's practice of evaluating each opioid application on its own.
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Gottlieb said the drug will carry a boxed warning and won't be available at drugstores for patients to take home.
US regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals. It notes that the Department of Defense was involved in its development and that it was a priority for the Pentagon because it "fills an unmet need". The study demonstrated that patients receiving the drug experienced significantly greater pain reduction versus placebo over the first 12 hours post-treatment. Alan says the concern around the drug is "valid given the potential for abuse".
Dsuvia was rejected by an FDA advisory committee in 2017 because the committee wanted more data.
"I am very disappointed with the decision of the agency to approve Dsuvia". Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.
The FDA has approved a new sublingual formulation of sufentanil, Dsuvia, for the management of acute pain in adults in medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.