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FDA approves opioid painkiller 1,000 times stronger than morphin

07 November 2018

In a highly controversial move, the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the medicine could be a "danger" to public health. The tiny pill - just three millimeters in diameter - is likely to worsen the nation's drug crisis, according to critics and the head of the FDA's advisory committee on painkillers.

"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?"

As the worst drug crisis in US 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. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country.

Gottlieb is committed to bringing a plan the FDA's Opioid Policy Steering Committee and maybe even the Congress. "Addressing it is a public health priority for the FDA".

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What makes this particular approval so interesting is that the drug has many outspoken critics. The drug is 30-microgram in pill form. Each would come in a plastic applicator that looks like a syringe.

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.

"To address concerns about the potential risks associated with Dsuvia, this product will have strong limitations on its use", Gottlieb said.

"As a single-dose, non-invasive medication with a rapid reduction in pain intensity, DSUVIA represents an important alternative for healthcare providers to offer patients for acute pain management", Dr. David Leiman, clinical assistant of surgery at University of Texas at Houston, said in a statement from AcelRx. A spokeswoman said the company is not providing information on expected sales.

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In approving the drug, the agency skirted its normal vetting process, these critics say.

An FDA advisory committee did recommend for approval of Dsuvia in a 10-3 vote last month.

Although the FDA is committed to reducing the opioid crisis and despite their claims to work in the interest of addiction-free drugs, the latest opioid may go against everything that has been said.

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.

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Sidney Wolfe of Public Citizen's Health Research Group, a consumer group, called Gottlieb's statement "empty rhetoric" and said the agency missed a big opportunity when it approved the pill. "It will be taken by medical personnel and others for whom it has not been prescribed".

FDA approves opioid painkiller 1,000 times stronger than morphin