FDA WARNING_LETTER - AcelRx Pharmaceuticals, Inc. - February 16, 2021

The FDA's Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to AcelRx Pharmaceuticals, Inc. regarding promotional materials for DSUVIA (sufentanil) sublingual tablet, CII. The reviewed "SDS Banner Ad" (PM-US-DSV-0018) and a tabletop display (PM-US-DSV-0049) were found to make false or misleading claims about DSUVIA's risks and efficacy, thus misbranding the drug under the Federal Food, Drug and Cosmetic Act (FD&C Act).

Key violations include: 1. **Misleading Administration Claims**: The phrase "TONGUE AND DONE" in both materials implies a simple, one-step administration, contradicting the multi-step process, including visual confirmation of tablet placement, outlined in the Prescribing Information (PI). This oversimplification is concerning due to the serious risks of accidental exposure, overdose, and diversion associated with the potent, small tablet. 2. **Omission of Material Dosing Information**: The banner states "Minimum redosing interval 1 hour" and "Average redosing interval 3 hours" but omits the critical "Do not exceed 12 tablets in 24 hours" from the PI, creating a misleading impression about safe use and increasing overdose risk. 3. **Inadequate Conveyance of Limitations of Use**: The banner claims "DSUVIA® comes in one