Published: Wed, November 07, 2018
Health Care | By Cedric Leonard

Amid deepening addiction crisis, FDA approves powerful new opioid

Amid deepening addiction crisis, FDA approves powerful new opioid

The FDA announced its approval November 2 of a new prescription opioid called Dsuvia, despite public and medical criticism for the drug's approval in the midst of the opioid epidemic, according to STAT.

"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.

Along with the approval, Commissioner Scott Gottlieb released a statement of more than 2,200 words explaining the decision as well as how the agency will consider future opioid applicants. The objective, of course, was for the committee to determine the drug's overall safety and efficacy; and the FDA usually follows whatever guidance their committees provide.

"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. 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. Other news on opioids focuses on the FDA's armed hunt for counterfeit drugs and the continued threat of fentanyl and heroin. Critics point out that this comes amid an opioid epidemic in the United States - which led to more than 72,000 deaths in 2017 alone.

He also called the drug "a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation's soldiers on the battlefield".

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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.

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

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.

AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe.

"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. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients. She said caregivers can make these mistakes as they calculate the amount of clear liquid painkillers such as morphine to administer intravenously.

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