FDA Approves Controversial New Opioid

FDA approves powerful opioid despite fears of more overdose deaths

Democratic Senator Ed Markey of MA urged the FDA not to approve the painkiller last month, saying "an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill."To that, FDA Commissioner Scott Gottlieb said in a statement that "very tight restrictions" will be placed on Dsuvia.Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said".

Kolodny called Dsuvia an "exceptionally dangerous" drug that is 10 times stronger than fentanyl, which is 50 times stronger than heroin.

A new tablet form of an ultra-powerful opioid is about to make its way into hospitals, despite the ongoing opioid crisis plaguing the U.S. According to critics, the decision will only fuel the United States' drug crisis even further rather than improving it.

The medication should not be used for more than 72 hours at a time, according to the FDA.

Gottlieb said the drug will carry a boxed warning and won't be available at drugstores for patients to take home. It's an alternative to IV painkillers used in hospitals. The FDA commissioner has also taken an unusual stance by saying that he wants more authority for the agency to consider similar drugs in the market which would make it easier for the agency to turn down applications for opioids in the future.

Leading the dissent was Raeford Brown, the chairman of an FDA advisory committee that reviewed AcelRx Pharmaceuticals' Dsuvia last month and ultimately recommended its approval in a 10-3 vote.

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Additionally, four Democratic senators had urged Gottlieb to deny approval on Dsuvia until Brown and other drug safety committee members could participate in the decision and vote, in a letter they sent last Wednesday.

The Food and Drug Administration is facing criticism over the approval of a drug called Dsuvia.

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

"DSUVIA will not be available in retail pharmacies or for outpatient use". The FDA endorsed Dsuvia, which can be applied once under the tongue and benefit soldiers on the battlefield where IVs can be impractical. Company executives said they expect to launch Dsuvia in the first quarter of 2019. As such, "We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", said AcelRx's CEO, Vince Angotti, in a statement.

And even as his agency gave the nod to Dsuvia, Gottlieb said other steps are being taken to restrict access to highly potent opioids.

In one study, the pill provided about the same pain relief to patients as IV morphine.

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