FDA approves opioid stronger than fentanyl

FDA approves new opioid

The U.S. Food and Drug Administration approved a powerful new opioid medication on Friday, in spite of major concerns raised by health advocates that the drug's strength and design could prove harmful for patients and the public. The group noted that Dsuvia is five to 10 times more powerful than fentanyl and 1,000 times more potent than morphine.

"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", he said.

Medical professionals administer Dsuvia underneath the tongues of patients with an applicator that releases the opioid in tablet form. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.

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.

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One factor that weighed heavily in the Dsuvia decision is military interest in the drug, Gottlieb said in his statement. "It can't be dispensed to patients for home use and should not be used for more than 72 hours".

The same drug, with the chemical name sufentanil, is already available as an IV medication.

Sanjay Gupta that opioids are the biggest crisis facing the nation, a crisis fueled by overprescribing. There are also "very tight restrictions being placed on the distribution and use of this product", Gottlieb says.

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

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"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 related to battlefield wounds", he wrote.

Pamela Palmer, an anesthesiologist, said she founded the company to reduce the number of deaths caused by opioid dosing errors in hospitals and ambulatory care centers.

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says. It is the tablet version of an opioid that's now marketed for intravenous delivery, and was also approved in Europe just last July under the brand name Dzuveo. It will not be available at your local pharmacy and is designed only for use in a "certified medically-supervised healthcare settings".

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