FDA approves opioid 10 times stronger than fentanyl

The FDA announced its approval Nov. 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.

Here are four things to know:

1. Dsuvia is a tablet version of an intravenous opioid and dissolves under the tongue. Dsuvia was a priority for the Pentagon because its unique properties make it suited for military use, which was a factor in the FDA's approval.

2. The FDA advisory committee recommended Dsuvia's approval in October, but was urged by critics not to endorse the drug because it's 10 times more powerful than fentanyl and could be diverted by medical personnel. Besides leaders in the medical community, Sens. Edward Markey, D-Mass., Claire McCaskill, D-Mo., Joe Manchin III, D-W.Va., and Richard Blumenthal, D-Conn., wrote a letter to the FDA opposing its decision.

3. FDA Commissioner Scott Gottlieb, MD, said Dsuvia's different formulation and battlefield applications allow the FDA to fit the drug into an "overall drug armamentarium."

"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds. The military application for this new medicine was carefully considered in this case," Dr. Gottlieb said in a statement.

4. Dr. Gottlieb also mentioned the FDA will reformat how it evaluates opioid medication by developing a "formal benefit and risk framework." This will help the FDA evaluate future opioid medication safety and efficacy. Dr. Gottlieb indicated the FDA will re-evaluate its consideration of individual and public health impacts of new approved opioids entering the market.

"I recognize that the debate goes beyond the characteristics of this particular product or the actions that we're taking to mitigate this drug's risks and preserve its differentiated benefits. We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval — the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction," Dr. Gottlieb said.

More articles on opioids:

Opioid use may up atrial fibrillation risk by 34%

How U of Tennessee Medical Center cut opioid use in half

NYC Health + Hospitals increases buprenorphine access to patients citywide

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