FDA rebukes AcelRx for flippant 'tongue and done' promo for potent opioid drug Dsuvia

The AcelRx banner promotions submitted to the FDA (above) for approval got the opioid drug maker a warning letter for being misleading. (FDA)

The FDA promo police aren't done with opioid marketers yet. And the Office of Prescription Drug Promotion's (OPDP's) first warning letter of 2021 is notable even among the rapping fentanyl pill bottle promotions of yore.

Drugmaker AcelRx got slapped down for banner and table flyer promotions using the pithy slogan “tongue and done” to promote Dsuvia, an opioid painkiller dosed as a single pill under the tongue—and that happens to be five to 10 times stronger than fentanyl.

In an unusual extra step alongside the warning letter, the agency's Center for Drug Evaluation and Research issued a statement criticizing the simplistic tagline.

“The claim ‘Tongue and Done’ severely detracts from these important conditions for safe use,” the statement says. “Because of the potency and the small size of the tablet, the prescribing information outlines multiple administration steps including a separate, distinct step to visually confirm tablet placement in the patient’s mouth.”

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The OPDP warning letter more clinically labels the promotions "false and misleading" on risks and benefits, pointing to the slogan and several other missteps.

The agency pointed to specific problems with the banners' wording, font size and colors. One line, for instance, points to Dsuvia's “minimum redosing interval (of) 1 hour.” That's misleading, OPDP said, because it leaves out an important caveat: Dsuvia's official label cautions against taking more than 12 tablets in 24 hours.

Another line in the ad claims “one strength for acute pain,” which OPDP dinged as inadequate. The language was too simple and excludes the strict limitations on Dsuvia's use. The agency even criticized the large font size used to tout the drug's benefits compared to the much smaller lettering disclosing risk information.

Some opioid marketers in recent years have been criticized for overly aggressive sales tactics with lawsuits ensuing. In one widely rebuffed marketing tactic, an Insys Therapeutics executive danced and rapped in a fentanyl spray bottle at a national sales conference.

Dsuvia was developed in collaboration with the Department of Defense with an eye toward military use. It was approved in 2018 with a risk-management plan that limits its use to healthcare facilities and requires medical supervision. Still, the approval was widely criticized as unnecessary and potentially dangerous.

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The FDA’s own opioid advisory committee chair, Raeford Brown, M.D., warned against the approval—and, after the agency issued its green light, he co-authored a column in The Washington Post saying the agency “made the wrong call.” Along with the drug's inherent dangers, Dsuvia had “limited efficacy and no unique benefits,” the column opined.

Around the same time, Sen. Richard Blumenthal, D-Connecticut, appeared at a press conference with fire fighters and police officers, saying the drug would inevitably move to the street, pouring gasoline on already raging opioid-addiction fire.

Then-FDA Commissioner Scott Gottlieb, M.D., defended the decision in a lengthy statement, noting in part, “I believe that the unique aspects of Dsuvia, including those that make this drug a high priority for the Pentagon, differentiate this new formulation of sufentanil from other sufentanil products in a way that is consistent with population-based considerations for how it fits into the overall drug armamentarium.”