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Posted 16 February 2021 | By Michael Mezher 

OPDP warns AcelRx over Dsuvia promotional materials

2820 In its first warning letter of the year, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) last week cited AcelRx Pharmaceuticals over promotional materials for its opioid analgesic Dsuvia (sufentanil sublingual tablet).
Specifically, the warning letter cites the company for false and misleading claims made in banner ads and a tabletop display that feature a tagline promoting the ease of administration of Dsuvia as “Tongue and Done.”
OPDP enforcement actions have remained low in recent years, with only six warning and untitled letters sent to drugmakers in 2020. Since 2015, OPDP has sent fewer than 10 untitled and warning letters in all but two years, 2019 and 2016. (RELATED: OPDP sends first untitled letter of 2020 to Xeris over Gvoke TV spot, Regulatory Focus 20 August 2020).
This latest letter comes nearly two-and-a-half years after FDA approved Dsuvia for acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The drug is also subject to a risk evaluation and mitigation strategy (REMS) that restricts its use to certified medically supervised healthcare settings. (RELATED: FDA approves new opioid opposed by Markey and others, Regulatory Focus 2 November 2018).
The prescribing information (PI) for Dsuvia also includes an extensive boxed warning, which details the risks for accidental exposure, life-threatening respiratory depression and addiction, abuse and misuse, as well as a laundry list of contraindications and other warnings and precautions.
“The promotional communications, the banner and display, make false or misleading claims and representations about the risks and efficacy of DSUVIA. Thus, the banner and display misbrand Dsuvia within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and make its distribution violative,” FDA writes, adding that, “Oral opioids, such as Dsuvia, include risks for accidental ingestion, which may lead to fatal respiratory depression.”
In the warning letter, FDA takes issue with AcelRx’ “Tongue and Done” claim, which is paired with an image of a single-use applicator device, as “oversimplifying the administration process” of the drug.


“These presentations are misleading because they imply that the administration of Dsuvia consists of a simple, one-step process, when this is not the case,” FDA writes, noting the “numerous administration steps outlined in the PI, including a separate, distinct step to visually confirm tablet placement in the patient’s sublingual space of the mouth.”
“Given the potency and the small size of the tablet, the risk of misplaced tablets is a serious safety concern to the patient and others,” FDA adds.
FDA says such misrepresentations are “particularly concerning” given that a REMS program was mandated to highlight the risk of respiratory depression that can occur due to accidental exposure.
The agency also raises concerns about dosing claims made in the banner, including the minimum dosing interval of one hour and average redosing interval of three hours, as they omit information about the maximum daily dosage of 12 tablets in 24 hours. “This omission is concerning due to the resinous risks associated with overdose of Dsuvia, including respiratory depression and death,” FDA said in a statement.
Additionally, FDA says the claim made at the top of some of the banners that Dsuvia “comes in one strength for acute pain” create a misleading impression about the drug by leaving out information about its limitations of use. The warning letter also cites the contrast between benefit claims in the banner, which feature a color background and large font, with the full indication and limitations of use, which are only accessible if viewers scroll through paragraphs of text in the Important Safety Information portion of the banner.
Lastly, FDA says the promotional materials failed to present information about the Boxed Warning, Contraindications, Warnings and Precautions and Adverse Reactions “with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of Dsuvia.”
Warning Letter, Statement


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