FDA approves a powerful new opioid, rejecting criticism from advisers

FDA approves new opioid

FDA approves new opioid

The medication should not be used for more than 72 hours at a time, according to the FDA. The medication is called DSUVIA; it is a single-dose 30 mcg sublingual tablet of sufentanil. 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. Other news on opioids focuses on the FDA's armed hunt for counterfeit drugs and the continued threat of fentanyl and heroin. "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.

The product, Dsuvia, consists of the synthetic opioid sufentanil, which is 500 times stronger than morphine, packaged in a plastic applicator for faster pain relief.

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The chair of an FDA advisory panel that considered whether the drug should be approved, Dr. Raeford Brown, called it a "danger to the general public health" last month. 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. One stipulation of its stamp of approval was that the drug can only be administered within the walls of designated facilities like hospitals, surgical centers and emergency rooms, USA Today reported.

In a November 2 statement released by the consumer group Public Citizen, the chairman of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee criticized the decision, reiterating his opposition he had previously voiced last month in a letter to FDA leaders. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths. AcelRx returned to the committee this year, and on October 12 the drug was recommended for approval. Others weren't convinced that the drug's benefits outweighed potential risks.

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Still, critics hold that the drug does not serve a unique need, despite its seemingly more controlled administration environment. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients. "The FDA has implemented a REMS that reflects the potential risks associated with this product and mandates that Dsuvia will only be made available for use in a certified medically-supervised heath care setting, including its use on the battlefield".

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