When we’re hearing so much about an opioid crisis, it would seem like the last thing we need is another such drug on the market. Yet the FDA has not only approved a new synthetic opioid—but the drug is 1,000 times more potent than morphine. You may be asking yourself, Are they crazy? Good question! Here are some answers…
Sufentanil (Dsuvia), the newly approved drug, is a sublingual tablet. The drug has already been in use for several years as both an intravenous and epidural injection for anesthesia. The new tablet form will be available only in one strength and will be preloaded into a dispenser that releases the tablet under the tongue where it is left to dissolve. Dsuvia is intended to be used only for rapid relief of severe pain and only in medical facilities…and it should be dispensed only by a licensed or supervised health-care provider. It will not be available by prescription for home use. The only exception to the medical-facility restriction will be use on a battlefield.
As might be expected, the FDA’s announcement of its approval has sparked considerable controversy…
Critics, including consumer advocacy, public health and health-care professionals, say that this drug does not add any benefits that are not already available from other drugs—while warning that it does contribute very serious additional dangers to an already-overwhelming opioid crisis. They cite the example of fentanyl, another synthetic opioid, that was approved by the FDA in 1984. Fentanyl was developed to be used only as an anesthetic but is now a tragically popular street drug. In 2017 alone, fentanyl killed close to 30,000 Americans. Dsuvia is up to 10 times stronger than fentanyl. It is naive to think, the critics warn, that Dsuvia won’t also eventually make its way to the street, where it will pose a new and more potent risk for addiction, overdose and death.
In defense of its decision, the FDA argues that the potency of Dsuvia is deceptive. The only dose in which it will be available is very small—30 micrograms (mcg), equivalent to the common dose of intravenous morphine, 5 milligrams (mg). They also point out that Dsuvia does have the advantage of bringing pain relief more quickly than IV morphine—in as short a time as six minutes, with relief lasting about three hours. (Fentanyl also can provide relief in minutes, while morphine can take up to 30 minutes to take effect, and relief lasts for several hours with both drugs.) In fact, the Department of Defense worked closely with the drug developer, AcelRx Pharmaceuticals, Inc., and wants the drug for battlefield injuries.
The FDA further notes that Dsuvia will not be approved for more than 72 hours of use, with a maximum of 12 tablets in 24 hours. It will come in a disposable, single-dose applicator, which should reduce the danger of drug overdose or abuse.
Other advantages: Dsuvia can be used under conditions when an IV can’t be started…when there isn’t a vein that can be used for injection…or when a person is unconscious or unable to swallow. Although fentanyl and morphine also can be given sublingually, Dsuvia dissolves and is absorbed much faster than morphine or fentanyl. Dsuvia is expected to be available in 2019. You won’t need to be injured in battle to get it—it may soon be the go-to drug for rapid pain relief in hospitals and emergency rooms, such as in cases where a person is injured or in severe pain and doing an IV is too difficult or time-consuming.