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OPDP Issues First Warning Letter of 2021

February 18, 2021

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has issued its first Warning Letter of 2021 to AcelRx Pharmaceuticals, Inc. for a violative SDS Banner Ad (banner) and a tabletop display for DSUVIA (sufentanil) sublingual tablet, CII (Dsuvia) that misbrands Dsuvia within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act). Dsuvia is indicated for use in adults in a certified medically supervised healthcare setting for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

According to the Agency, Dsuvia and other oral opioids include risks for accidental ingestion.  Dsuvia is therefore subject to a Risk Evaluation and Mitigation Strategy (REMS) that restricts its use to certain healthcare settings.  Dsuvia's  drug labeling also includes, among other things, strong limitations on its use, boxed warnings and detailed administration instructions. 

As stated in the Warning Letter, the banner includes the claim, “DSUVIA® comes in one strength for acute pain. . . TONGUE AND DONE.” The tabletop display also includes the prominent claim “TONGUE AND DONE”. OPDP finds these claims to be misleading as they imply a simple, one-step process for the administration of Dsuvia, which is different from the multiple administration steps outlined in Dsuvia's PI. One of these steps includes visually confirming tablet placement in the patient’s sublingual space of the mouth.

OPDP  discusses additional misleading claims included in the banner, such as “Minimum redosing interval 1 hour” and “Average redosing interval 3 hours*… *Shown over a 12-hour period in the pivotal trial.”  OPDP also notes that the banner omits material information from the DOSING AND ADMINISTRATION section of PI, which states, “Do not exceed 12 tablets in 24 hours.”  As per the Letter, the claims citing lesser interval hours create a misleading impression of safety.  OPDP further notes, "these violations are especially concerning from a public health perspective given the importance of the administration instructions intended to protect from the serious and potentially life-threatening risks that may result from the accidental exposure to misplaced tablets of Dsuvia or overdosage with Dsuvia."

Additionally, OPDP cites that the materials also failed to present important safety information in a manner that included "prominence and readability reasonably comparable with the presentation of information relating to the benefits of Dsuvia." The Letter includes factors that may impact such prominence and readability.  

The requested action of OPDP includes, among other things, "that AcelRx cease any violations of the FD&C Act as discussed in the letter, and notes that failure to adequately address this matter may lead to regulatory action."

 

A copy of the Warning Letter is available here.  

 

For more information regarding OPDP Enforcement Letters, please see the OPDP Promotional Violations section of the Enforcement Actions Database.

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