MA pols wary of new Rx opioid

FDA approves new opioid

The Food and Drug Administration's approval of a powerful new opioid stirred up fierce opposition in some consumer and healthcare circles after it was announced Friday, continuing debate about the agency's role and responsibility in the opioid crisis.

Public Citizen described the drug as "five to 10 times more potent than fentanyl and 1,000 times more potent than morphine".

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".

"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. The goal, of course, was for the committee to determine the drug's overall safety and efficacy; and the FDA usually follows whatever guidance their committees provide. "The agency is taking new steps to more actively confront this crisis while also paying careful attention to the needs of patients and physicians managing pain".

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Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said. "We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval - the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", Dr. Gottlieb said.

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. Indeed, its potential use by soldiers was one reason Dsuvia was approved, according to FDA Commissioner Dr. Scott Gottlieb.

But Dsuvia's approval comes amid controversy, with an epidemic of opioid abuse continuing to ravage the United States. Alan says the concern around the drug is "valid given the potential for abuse".

"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Sidney Wolfe, founder of Public Citizen's Health Research Group, said in a statement. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo. On October 12-so, not that long ago-AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee. The drug, Dsuvia, is a tablet form of sufentanil, a synthetic opioid that has been used intravenously and in epidurals since the 1980s. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.

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