FDA warns AcelRx over misleading pain drug ads

Feb. 16, 2021

The U.S. Food and Drug Administration has issued a warning letter to AcelRx Pharmaceuticals over false or misleading claims in its promotional communications in relation to the risks and efficacy of Dsuvia (sufentanil sublingual tablet), an opioid analgesic.

According to the FDA, the promotional communications, the banner and display, make false or misleading claims and representations about the risks and efficacy of Dsuvia. Thus, the banner and display misbrand Dsuvia within the meaning of the Federal Food, Drug and Cosmetic Act and make its distribution violative.

AcelRx have been sending out ads that downplay prescribing conditions required for the safe use of Dsuvia. The opioid was approved with special restrictions requiring that it only be prescribed in a certified medically supervised setting by health care practitioners trained to properly administer it. However, AcelRx have promoted the product as simple to administer, which undercuts the FDA-required conditions on the proper administration of the drug.

Dsuvia is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is of particular use in certain special circumstances where adult patients may not be able to swallow oral medication and where access to intravenous pain relief is not possible.

Dsuvia was approved with a Risk Evaluation and Mitigation Strategy (REMS), which reflects the serious risks associated with this product. The REMS limits distribution to certified, medically-supervised health care settings where health care professionals are trained in the proper use and administration of the product.

The FDA takes particular umbrage with AcelRx's use of the slogan "Tongue and Done,” which it says severely detracts from the critical conditions necessary for the drug's safe use.

Read the FDA statement