FDA approves a powerful new opioid, rejecting criticism from advisers

FDA OKs powerful opioid pill as alternative to IV painkiller

FDA OKs powerful opioid pill as alternative to IV painkiller

Others weren't convinced that the drug's benefits outweighed potential risks.

"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. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths.

One factor that weighed heavily in the Dsuvia decision is military interest in the drug, Gottlieb said in his statement.

The New York Times: F.D.A.

The FDA is taking some precautions in the hopes that the drug will not be abused.

"Because of the risks of addiction, abuse and misuse with opioids; Dsuvia is also to be reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia", according to a statement from Gottlieb about the drug's approval.

Dsuvia (sufentanil) is an exceptionally powerful opioid, roughly 1,000 times stronger than morphine and more potent than fentanyl.

"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.

"We need to address the question that I believe underlies the criticism raised in advance of this approval", Gottlieb wrote.

"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 drug is intended for use within health-care settings and perhaps on the battlefield. The pill from AcelRx Pharmaceuticals contains the same decades-old painkiller often given in IV form or injection to surgical patients and women in labor. Dr. Palmer says that the drug will not be dispensed to patients via pharmacy; instead, it can only be administered by a healthcare provider in a medical center.

Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said.

But this wasn't an Federal Bureau of Investigation sting or DEA operation.

Another criticism to be voiced is that Dsuvia is unnecessary: a drug that will not really add any benefit to an already saturated-and very unstable-opioid market. The OCI, it turns out, is staffed by 300 gun-toting officers, all of them employees of the same bureaucracy that issues food recall notices and verifies that medicines are safe and effective. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001.

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.

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