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# OPDP Cites ‘Misleading’ Nurtec ODT Video
- URL: https://www.fdaweb.com/opdp-cites-misleading-nurtec-odt-video/
- Published: 2021-03-10T12:00:00.000Z
- Updated: 2026-09-14T16:50:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148843

The CDER Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer video of an interview with **Khloé Kardashian**, a paid Biohave Pharmaceuticals spokesperson, which aired 7/15/20 on *The View* and also was the subject of an FDA Bad Ad Program complaint, contains false or misleading claims and representations about the risks associated with and efficacy of Nurtec ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use. A 3/8 [Notice of Violation](https://www.fda.gov/media/146528/download?ref=fdaweb.com) says the violations “are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the overall benefit a patient may expect as a result of Nurtec ODT treatment and minimizes the risks associated with taking the drug.”

Nurtec ODT is indicated for the acute treatment of migraines with or without aura in adults. The labeling contains a Warning and Precaution about hypersensitivity reactions.

OPDP says the video interview misleadingly suggests that patients treated with the drug will experience “relief” within 15 to 30 minutes of taking it. “While these claims may be an accurate reflection of the spokesperson’s own experience with Nurtec ODT, their personal experience does not adequately support the suggestion that the drug will provide ‘relief’ within 15 to 30 minutes,” the letter says. The letter also says that a super on the video indicating that treatment results may vary does not mitigate the misleading impression. “FDA is not aware of any data to support the claims that patients treated with Nurtec ODT will experience “relief” within 15 to 30 minutes,” the notice says.

OPDP also faults the ad for suggesting that Nurtec ODT is clinically superior to or more effective than other prescription and over-the-counter products when this has not been demonstrated. And it says the interview communicates that the drug is for the treatment of migraine but fails to adequately communicate its full FDA-approved indication and limitations of use.

“The video is misleading because it fails to present information relating to the Contraindications, Warnings, Precautions, and Adverse Reactions for Nurtec ODT with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of Nurtec ODT,” OPDP says.

Finally, the letter says the company failed to submit a copy of the video to OPDP at the time of initial dissemination, as required by regulations.

Biohaven was told to respond by addressing the concerns raised in the letter and listing all other promotional communications for Nurtec ODT that contain similar representations, with a plan for discontinuing the use of such communications or ceasing distribution of Nurtec ODT.