The Food and Drug Administration (FDA) has issued a warning letter to AcelRx Pharmaceuticals, the manufacturer of Dsuvia (sufentanil sublingual tablet), for disseminating false and misleading promotional communications that undermine key prescribing conditions required for its safe use.
Dsuvia, a potent opioid analgesic, is approved for use in adults in a certified medically supervised health care setting (eg, hospitals, surgical centers, emergency departments) for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The product should only be administered by a health care provider and is available only through a restricted program called the Dsuvia Risk Evaluation and Mitigation Strategy (REMS) Program.
The promotional communications flagged in the warning letter oversimplify the administration of the drug as “Tongue and Done.” However, the prescribing information for Dsuvia includes multiple steps for administration in order to minimize the serious risks associated with misplaced tablets. The Agency stated that “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.”
In addition, the promotional communications failed to include the maximum daily dosage of Dsuvia (12 tablets in a 24-hour period). The Agency warned that omitting this information could potentially lead to an overdose resulting in respiratory depression and death.
The Company will have 15 days from the date of receipt of the letter to address these concerns and provide the Agency with a plan of action to distribute truthful, non-misleading, and complete corrective communications.
Health care professionals can report potentially false or misleading advertising to the FDA’s Bad Ad program.
FDA issues warning to AcelRx for making false and misleading claims about the risks and benefits of Dsuvia. [press release]. Silver Springs, MD: US Food and Drug Administration; February 16, 2021.