The FDA Just Approved an Opioid That's 1,000 Times Stronger Than Morphine

The FDA approval of Dsuvia means there’s now another opioid on the market—an extremely powerful one. It’s 1,000 times more potent than morphine and 10 times more potent than fentanyl. Many people have expressed concern that this drug could make the opioid crisis worse, wondering “do we really need this on the market?” As with most medical advances, there are pros and cons.

The drug is a sublingual (under the tongue) version of sufentanyl, which was first made in 1974 and is given intravenously. On the benefit side, Dsuvia has a unique ability to provide high-level pain relief in a short time, without need for IV access. That means that trauma victims can get relief quickly, so one use for Dsuvia will be for medics who are literally on the battlefield; the Pentagon strongly supported approval of this drug. It may also be useful in the operating room to provide sedation and anesthesia, especially in people for whom it is difficult to get an intravenous line in, such as some people with cancer.

What are the downsides? Well, a drug so powerful that can be taken by mouth has the potential for abuse. Synthetic opioids, such as fentanyl, provide a “high” for many. However, just because the drug is a thousand-fold more potent doesn’t mean the “high” is a thousand times stronger: it just means that the dose that’s needed to have the effect is much less.

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The FDA has taken some common-sense steps to reduce the likelihood of abuse. The drug is going to be supplied in a single-use disposable container. It will not be available for home use or through retail pharmacies; only in “medically supervised” settings, such as hospitals or the military. The FDA has also mandated that Dsuvia will be “reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia.” It will also contain a “black box” warning, the highest warning the FDA issues to indicate there are serious hazards associated with the drug. None of these guarantee that the drug will not be abused, people being as they are, but it reduces the likelihood of misuse and diversion.

While the US continues to have a serious opioid problem, I don’t believe that the approval of Dsuvia is likely to significantly escalate it, given the precautions around it. While its uses in the ER and OR are marginal, it’s not a thousand or even ten times more dangerous than fentanyl, which is being synthesized and sold illicitly on the street. It does have unique benefits in certain situations that are worth adding to the medical toolkit, and in my opinion, those outweigh the risks in this case.

Keith W. Roach, M.D., FACP is an Associate Professor of Medicine at Weill Cornell.

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