Tox Tuesday: Despite controversy, FDA approves powerful new opioid painkiller

November 20, 2018

A highly potent opioid drug has gained U.S. Food and Drug Administration (FDA) approval, despite critics’ fears that another powerful opioid on the market will pose a public health threat.

The drug, going under the brand name Dsuvia, is an under-the-tongue tablet version of an already existing opioid, sufentanil, which is usually administered intravenously. Traditionally, sufentanil is an opioid analgesic used as an anesthetic for surgeries and other serious medical procedures, and must be injected or delivered with an I.V. It’s a Schedule II controlled substance in the U.S.

Opponents to Dsuvia’s approval note that it is five to 10 times more powerful than the synthetic opioid fentanyl, which is already around 100 times more powerful than morphine. Just three milligrams of pure fentanyl can kill an adult.

“There are very tight restrictions being placed on the distribution and use of this product,” said FDA Commissioner Scott Gottlieb in a statement. “We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia.”

With the opioid crisis continuing to occupy a prime spot in the conversations of the medical and pharmaceutical communities, many experts have questions regarding the impact of adding another powerful opioid to the market. Does it increase opportunities for people to accidentally overdose? Does it create more chances for patients to misuse their prescriptions? Does it make it easier for doctors to make prescriptions that might not be medically appropriate?

Gottlieb addressed these questions in his statement, pondering how the FDA should balance the mix of medications already available, new ones that might fill medical needs, and the risk of contributing to the current epidemic of opioid misuse. He doesn’t offer solutions but reasserts that the FDA is considering all of this as it moves forward.

Those in favor of the drug note that it has useful applications for the military as a battlefield medication, since it can be given to wounded soldiers without the need for needles. The drug was developed with the partnership of the U.S. Department of Defense.

Dsuvia’s manufacturers are required to maintain a risk mitigation plan to decrease the chances that the drug will be abused by tightly controlling its distribution. It can’t be carried at retail pharmacies, can’t be used for more than 72 hours and won’t be dispensed for at-home use.

More about the drug

Dsuvia is a sublingual formulation of sufentanil that is delivered using a disposable, pre-filled applicator. It’s intended to be used only in a medical environment by a qualified health care professional. According to its manufacturers, it was designed to be a single-strength tablet with single-unit packaging to reduce the potential for dosing errors and diversion. It’s set to hit the market in early 2019.

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