FDA Issues Warning to AcelRx for Making False and Misleading Claims About the Risks and Benefits of Dsuvia (sufentanil) 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. For full announcement, click here Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA