FDA Approves Powerful Opioid Pill That’s 10 Times Stronger Than Fentanyl

FDA approves new opioid

A new ultra-powerful opioid is about to make its way into hospitals.

Officials with the FDA have approved a new opioid, (Dsuvia, AcelRx Pharmaceuticals), sparking some controversy in the media that the opioid has potential for abuse.

Kolodny called Dsuvia an "exceptionally dangerous" drug that is 10 times stronger than fentanyl, which is 50 times stronger than heroin. And it should only be administered by a health care provider using a 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.

He also stated he believes FDA approval for opioids should come "within a broad public health context", one that acknowledges other opioids on the market, alternative therapeutic options, the ongoing epidemic and the risk for further abuse.

FDA Commissioner Scott Gottlieb announced approval of AcelRx Pharmaceuticals' painkiller Dsuvia Friday, an announcement that largely went under the public's radar, except for a swift denouncement by U.S. Sen. "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.

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.

The sublingual administration makes Dsuvia an option for patients with nothing by mouth (NPO) status and patients with hard IV access (obese, elderly, burn or needle-phobic patients), according to the statement. It would not be available in retail pharmacies.

Other restrictions, according to the FDA, include that it cannot be used for more than 72 hours and will have the same black-box warnings as are required for all opioids about the risk of misuse and abuse that can lead to addiction and overdose death. The numbers say it all: More people die in the USA each year from drug overdoses than from breast cancer.

"I am very disappointed with the decision of the agency to approve Dsuvia". Dr. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, urged the FDA to reject the drug.

AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe. It is expected to be available in the first quarter of next year.

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.

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