The powerful synthetic opioid Dsuvia, approved by the FDA in 2018, is still the subject of controversy:

The military advocated for its development but has not bought much of it, according to Yahoo News.1

The manufacturer now wants to advocate for use in the civilian market, saying the drug can offset shortages of medications during the coronavirus disease-2019 (COVID-19) pandemic.

And federal law enforcement says it is a dangerous drug that will only fuel the opioid epidemic in the country.1

It has been almost 2 years since the controversial 10-3 vote by the FDA to approve the ultrapotent opioid tablet Dsuvia, which was developed in cooperation with the Pentagon. The military joined Dsuvia's manufacturer in advocating for its approval as a way to treat pain in the field. (Topics in Pain Management covered the controversial approval in its January 2019 issue, Vol. 34, No. 6).

Here is what has happened since then:

* In May 2019, a Federal Bureau of Investigation (FBI) intelligence bulletin marked "for official use only," warned that this new drug would likely exacerbate the nation's opioid crisis.

* The FBI warning about Dsuvia was dire. "Because of its potency, Dsuvia likely will cause deaths at a rate surpassing that associated with fentanyl, increasing the overall opioid-related death rate in the near term," said the bulletin, which Yahoo News obtained and reported, saying the bulletin had not previously been made public.

* The military has yet to purchase the drug in large quantities, according to the article in Yahoo News.

* And now the manufacturer, AcelRx Pharmaceuticals, is actively pursuing the civilian market.

Dsuvia is 1000 times more powerful than morphine, delivered in a tiny pill smaller than a Tic Tac. Advocates of the drug say it addresses a military need, and AcelRx leaders claim that particularly now with the coronavirus pandemic driving shortages in some drugs, it could fill an unmet need in hospitals and help prevent overdoses with liquid opioids.

In a video interview by Yahoo News, Andrew Kolodny, MD, notes that no one should be surprised that AcelRx is marketing this drug to the private sector, not just for the military.2

"We're hearing a story that there was a need for this product and that a pharmaceutical company was there to meet the need. I don't buy it," Kolodny told Yahoo News in the video. "When a drug company gets its medicine approved by the FDA, it doesn't just sit on its hands and hope that doctors will prescribe this product that they invested millions in. They do everything they can to let the medical community know that this new product exists, and they do everything they can to get the medical community to prescribe this new product."

Kolodny is co-director of the Opioid Policy Research at Brandeis University. He also is executive director of Physicians for Responsible Opioid Prescribing, an organization with a mission to reduce morbidity and mortality caused by overprescribing of opioid analgesics.3

"One of the problems with approving new opioids is public health agencies are trying to get the medical community to prescribe more cautiously," Kolodny said in the video. "They're trying to get doctors to prescribe less opioids."

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