FDA Approves Powerful Opioid Pill as IV Painkiller Alternative

FDA approves new opioid

FDA approves new opioid

However, the approval indicates the opioid is to only be used in certified medically supervised health care settings, such as hospitals, surgical centers, and emergency departments.

Dsuvia (sufentanil) is an exceptionally powerful opioid, roughly 1,000 times stronger than morphine and more potent than fentanyl. The drug is supplied in a 30 microgram tablet in a single-dose, prefilled applicator for administration by a healthcare professional, and it will not be available in retail pharmacies or for outpatient use. Dr. Gottlieb indicated the FDA will re-evaluate its consideration of individual and public health impacts of new approved opioids entering the market. In a lengthy statement, Scott Gottlieb, FDA Commissioner, said there will be "very tight restrictions" placed on its distribution and it is intended only for supervised settings like hospitals.

"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group.

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".

USA regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it.

According to the FDA's statement, the drug was designed for military use, and while no one wants soldiers to suffer, some may argue that in the war against opioid-related overdoses, there are plenty of battlefields right here at home-with more than 115 people dying after overdosing on opioids every single day in the United States. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine. In its newly approved form, it is an option for patients with acute pain who are not able to receive an IV or are unable to swallow a pill. AcelRx returned to the committee this year, and on October 12 the drug was recommended for approval. But Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the committee, then took the rare step of publicly condemning that decision and urging the FDA to reject the drug. It is expected to be available in the first quarter of next year.

The manufacturer, a California company called AcelRx, will market the drug beginning in early 2019 under the name Dsuvia, at a wholesale price of $50 to $60 per dose. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

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