Published: Wed, November 07, 2018
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FDA Approves Opioid Drug 1,000 Times Stronger than Morphine

FDA Approves Opioid Drug 1,000 Times Stronger than Morphine

Experts and elected officials are lambasting the Food and Drug Administration for approving a new opioid that is 500 times stronger than heroin as the nation is in the grip of an addiction crisis.

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.

Medical professionals administer Dsuvia underneath the tongues of patients with an applicator that releases the opioid in tablet form. "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".

Critics are blasting the FDA for approving Dsuvia as the country faces increasing opioid overdose deaths.

To that, FDA Commissioner Scott Gottlieb said in a statement that "very tight restrictions" will be placed on Dsuvia.


"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.

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. The numbers say it all: More people die in the U.S. each year from drug overdoses than from breast cancer. Gottlieb noted Dsuvia was "a priority medical product for the Pentagon" and the military's use "was carefully considered in this case".

According to the FDA's statement, the drug was designed for military use, and while no one wants soldiers to suffer, some may argue that in the war against opioid-related overdoses, there are plenty of battlefields right here at home-with more than 115 people dying after overdosing on opioids every single day in the United States. Diversion, of course, is the term used to describe how drugs end up in the hands of someone other than the intended patient.

Gottlieb also points out in his statement that it can help in special circumstances in which a patient may not be able to swallow, adding that there could be potential uses on the battlefield. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine. Alan says the concern around the drug is "valid given the potential for abuse". Dr. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, urged the FDA to reject the drug. It is expected to be available in the first quarter of next year. On October 12-so, not that long ago-AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee.

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