Opioid 500 times stronger than morphine gets OK

FDA approves powerful opioid despite fears of more overdose deaths

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". Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.

A new ultra-powerful opioid is about to make its way into hospitals. Indeed, its potential use by soldiers was one reason Dsuvia was approved, according to FDA Commissioner Dr. Scott Gottlieb. As part of the program, the drug maker will monitor distribution and audit wholesalers' data, evaluate proper use in the healthcare setting, and monitor for diversion or abuse and decertify any healthcare setting that is noncompliant. The drug itself is only allowed for use in health-care settings and perhaps the battlefield and is not available to be sold separately at retail pharmacies.

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.

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.

"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain", Gottlieb said in an agency news release. "The military application for this new medicine was carefully considered in this case", Dr. Gottlieb said in a statement.

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.


"I am very disappointed with the decision of the agency to approve Dsuvia".

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.

The medication should not be used for more than 72 hours at a time, according to the FDA.

The United States continues to struggle with the opioid abuse epidemic.

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says. Acknowledging the criticism, he said he's asked FDA staff to "evaluate a new framework" for the approval of new opioid drugs that will clearly outline how the agency considers benefits and risks.

There's more on pain control at the American Society of Anesthesiologists.

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