The FDA issued a warning letter to AcelRx Pharmaceuticals, Inc. (AcelRx) accusing the company of “false and misleading” advertisement of sufentanil sublingual tablets (Dsuvia) that may undermine the conditions for safe use of the drug.
Use of sufentanil — a powerful opioid analgesic indicated to treat acute pain in adults for whom alternative treatments prove inadequate — is associated with serious risks. The drug comes with a Boxed Warning stating that the drug can cause life-threatening respiratory depression and opioid addiction, abuse, and misuse, and that concomitant use with CYP3A4 inhibitors can result in fatal overdose. For these reasons, the FDA approved sublingual sufentanil tablets with a Risk Evaluation and Mitigation Strategy (REMS) that outlines these dangers and limits the drug’s distribution to “certified, medically supervised health care settings where health care professionals are trained in the proper use and administration of the product.”
And, according to the FDA, the manufacturer’s promotional materials, with its simplified “Tongue and Done” slogan, “dangerously undercuts FDA-required conditions on the proper administration of the drug.”
“Critical conditions for the safe use of Dsuvia are not appropriately conveyed in the promotional communications cited in the warning letter,” the FDA explained. “In particular, the claim “Tongue and Done” severely detracts from these important conditions for safe use. 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. These prescribed steps are designed to minimize the serious risk that misplaced tablets could cause to patients and others. The promotional communications at issue also omit other important risk information, further minimizing the serious risks associated with Dsuvia. For example, the materials state that patients may retake the drug in one-hour intervals but fail to state that the maximum daily dosage is 12 tablets in 24 hours. This omission is concerning due to the serious risks associated with overdose of Dsuvia, including respiratory depression and death.”
The FDA demanded that AcelRx address these violations and submit a written response to the agency within 15 days addressing the agency’s concerns, listing any other promotional materials that contain similarly misleading statements, and explaining plans for discontinuing use of these advertisements or for ceasing distribution of the drug altogether. In addition, the FDA requested that AcelRx turn in a plan of action “to distribute truthful, non-misleading, and complete corrective communications about the concerns discussed in the warning letter to the audience(s) that received the promotional communications.”
If the manufacturer fails to meet these requirements, the agency threatened further regulatory action.
The FDA suggested that healthcare providers and consumers who encounter false or misleading prescription drug promotions file a report with the agency’s Bad Ad program.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 151
Topic ID: 88,151,393,730,192,151,725,925