Ruling against the recommendation of one of its chief experts, the U.S. Food and Drug Administration on Friday approved an extremely potent new opioid painkiller, Dsuvia.
Gottlieb said Dsuvia, which is administered under the tongue through a disposable, pre-filled, single-dose applicator, "is restricted to use in certified, medically supervised health care settings - such as hospitals, surgical centers and emergency departments - for administration by a health care professional".
That said, Gottlieb still acknowledged the concerns and criticisms over the approval, as well as how it opened a broader discussion about FDA policy about opioids.
Sanjay Gupta that opioids are the biggest crisis facing the nation, a crisis fueled by overprescribing. And many of those will overdose and die. "I recognize that the debate goes beyond the characteristics of this particular product or the actions that we're taking to mitigate this drug's risks and preserve its differentiated benefits".
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But the criticism was quick.
"This new opioid will soon be hitting the market in the middle of the worst drug crisis this country has ever seen", the Bay State senator said. Mine.Gottlieb said military use of the drug was "carefully considered in this case" as the FDA wants to "make sure our soldiers have access to treatments that meet the unique needs of the battlefield."More: Drugs kill more Americans than guns, cars and AIDS".
"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group. "To what extent should we evaluate each opioid exclusively on its own merits, and to what extent should we also consider.the epidemic of opioid misuse and abuse that's gripping our nation?"
The decision by the Food and Drug Administration came over objections from critics who fear the pill will be abused. Already, it's clear that in the context of the opioid crisis, "our evaluation of opioids is different than how we assess drugs in other therapeutic classes", Gottlieb noted.
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The Department of Defense was involved in the drug's development for soldiers injured in battle.
"I am very disappointed with the decision of the agency to approve Dsuvia".
Dsuvia was rejected by an FDA advisory committee in 2017 because the committee wanted more data. That panel recommended the drug's approval despite his warning.
The Redwood City, California-based company expects the pill to be available early next year at a price of $50 to $60 per pill. As such, "We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", said AcelRx's CEO, Vince Angotti, in a statement.
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