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# ‘False or Misleading’ Dsuvia Claims in Professional Promotion: OPDP
- URL: https://www.fdaweb.com/false-or-misleading-dsuvia-claims-in-professional-promotion-opdp/
- Published: 2021-02-16T12:00:00.000Z
- Updated: 2026-09-14T16:46:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148667

The CDER Office of Prescription Drug Promotion (OPDP) says a banner ad and tabletop display for AcelRx’ Dsuvia (sufentanil) sublingual tablets make false or misleading claims and representations about the drug’s risks and efficacy. A 2/11 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/acelrx-pharmaceuticals-inc-613257-02112021?ref=fdaweb.com) says oral opioids such as Dsuvia include risks for accidental ingestion and thus the drug is subject to a Risk Evaluation and Mitigation Strategy (REMS) that restricts its use to certain healthcare settings. The letter says the drug’s labeling includes strong limitations on its use and detailed administration instructions.

“These violations are especially concerning from a public health perspective,” OPDP says, “given the importance of the administration instructions intended to protect from the serious and potentially life-threatening risks that may result from the accidental exposure to misplaced tablets of Dsuvia or overdosage with Dsuvia.”

The letter says Dsuvia is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

There are several limitations on use included in the labeling and Boxed Warnings for accidental exposure and the Dsuvia REMS program; life-threatening respiratory depression; addiction, abuse, and misuse; specific cytochrome interactions; and risks from concomitant use with benzodiazepines or other central nervous system depressants.

OPDP says the banner ad omits information from the labeling on the maximum daily dosage and thus creates a misleading impression about the safe use of the drug. The banner also fails to convey material information about the drug’s limitations of use, thus creating a misleading impression, it says. The letter analyzes issues with other claims and statements in the promotional materials.

AxelRx was told to respond with a list of all Dsuvia promotional communications that contain representations like those listed in the letter and a plan for discontinuing the use of such communications or stopping the distribution of Dsuvia. The company also was told to submit a comprehensive plan to disseminate truthful, non-misleading, and complete corrective communications about the concerns expressed in the letter to the audiences that received the violative promotional materials.