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07 November 2018, 11:29 | Randall Craig
The FDA just approved an opioid painkiller 10 times more powerful than fentanyl
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 decision has met a lot of criticism because the opioid is 5-10 times more potent than pharmaceutical fentanyl. "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". Each pill, placed under the tongue for quick absorption, would have the same impact as five milligrams of intravenous morphine. FDA has restricted its use to certified medically-supervised health care settings only, such as hospitals, surgical centers, and emergency departments, and for administration by a health care professional.
Brown, four U.S. Senators and the advocacy group Public Citizen have predicted that Dsuvia will be diverted to illicit use and cause more opioid overdose deaths. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.
At the same time, FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market.
Other restrictions, according to the FDA, include that it cannot be used for more than 72 hours and will have the same black-box warnings as are required for all opioids about the risk of misuse and abuse that can lead to addiction and overdose death. For instance, it may not be administered at home, and can only be administered by a health care provider, which means that the drug will not be available at retail pharmacies. 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. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo. The single-strength tablet and single-unit packaging are created to mitigate the possibility of dosing errors, misuse and diversion. Company executives said they expect to launch Dsuvia in the first quarter of 2019.
An opioid policy steering committee is developing new guidance documents to help the FDA "consider the benefits and risks of these products in the context of the crisis".
As for Dsuvia, even after approval, "the FDA will continue to carefully monitor the implementation of the [regulatory safeguards] associated with Dsuvia and compliance with its requirements, and we'll work to quickly make regulatory adjustments if problems arise", Gottlieb said.
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