[2/16/2021] As part of the FDA’s ongoing commitment to combat inappropriate opioid use, the agency’s Center for Drug Evaluation and Research has issued a warning letter to AcelRx Pharmaceuticals, Inc. (AcelRx) for the false and misleading promotion of Dsuvia (sufentanil sublingual tablet), a potent opioid analgesic.
AcelRx has disseminated promotional communications that undermine key prescribing conditions required for the safe use of this opioid product. Dsuvia 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. The promotional communications at issue, however, promote the product as simple to administer -- just “Tongue and Done.” This promotion dangerously undercuts FDA-required conditions on the proper administration of the drug, which requires particular diligence to minimize the risk of serious or even fatal adverse events.
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. Such settings include hospitals, surgical centers and emergency departments that are certified in the requirements outlined in the REMS. The FDA continues to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements.
Critical conditions for the safe use of Dsuvia are not appropriately conveyed in the promotional communications cited in the warning letter. 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.
It is vitally important that promotional communications be truthful and non-misleading. Opioid products are highly addictive controlled substances and there are serious public health risks associated with their use, including addiction, abuse, and misuse, that can lead to overdose and death. False and misleading claims can negatively impact prescriber awareness and understanding about approved opioid drugs, their risks, and the actions and precautions necessary for the safe use of these products.
FDA requests that AcelRx cease any violations of the Food, Drug and Cosmetic Act and submit a written response within 15 days from the date of receipt of the letter addressing the concerns in the letter, listing all other promotional communications that contain statements such as those described in the letter, and explaining any plan for discontinuing use of such communications or for ceasing distribution of Dsuvia. If AcelRx fails to adequately address the concerns outlined in the warning letter, the FDA may take further regulatory action. The FDA is also requesting that AcelRx submit a comprehensive 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.
The FDA encourages healthcare providers and consumers to report potentially false or misleading prescription drug promotion to FDA’s Bad Ad program.
The FDA also encourages health care professionals and consumers to report adverse events, medication errors, and quality problems experienced with the use of any medical product to MedWatch: The FDA Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
The FDA remains focused on reducing the rate of new addictions by decreasing exposure to opioids while still enabling appropriate access for those patients who have legitimate medical need for these medicines. Dsuvia, when used in a manner consistent with the FDA-approved labeling, including the REMS, can play an important role in the management of pain. The agency will continue to actively confront the opioid crisis, while also paying careful attention to the needs of patients experiencing pain and their health care providers.