The FDA’s Office of Prescription Drug Promotion (OPDP) sent a March 8 Untitled Letter to Biohaven Pharmaceuticals over a direct-to-consumer video of an interview featuring Khloé Kardashian about the company’s Nurtec ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use.

“This video makes false or misleading claims and representations about the risks associated with and the efficacy of Nurtec ODT,” the Untitled Letter said.

“These 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.”

In addition, the video was not submitted to OPDP at the time of initial dissemination as required by 21 C.F.R. §314.81(b)(3)(i).

The Untitled Letter said that during the interview Kardashian “makes claims such as (in pertinent part): ‘… something that works in about 15-30 minutes...;” “It literally works within, for me, 15 minutes. And anyone with a migraine, for 15 minutes, of pure agony, they’re like knives in my head. So to have this relief, and to not be in a fog afterwards ... I’m able to just go with the rest of my day.”

OPDP contended “these claims misleadingly suggest that patients treated with Nurtec ODT will experience ‘relief’ within 15 to 30 minutes of taking the drug. 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 Untitled Letter contended that “claims that Nurtec ODT provides relief in 15-30 minutes are not supported by the clinical trial data. There were no pre-specified endpoints that evaluated the efficacy of the drug at 15 or 30 minutes after dosing. In addition, “according to the Clinical Studies section of the PI, the coprimary endpoints (freedom from pain and most bothersome symptoms) were measured beginning at 2 hours after dosing with Nurtec ODT and placebo. In addition, the PI states that, ‘In Study 1, statistically significant effects of NURTEC ODT compared to placebo were demonstrated for the additional efficacy endpoints of pain relief at 2 hours ....,’” the Untitled Letter said.

OPDP noted the video includes a super: “AS EVERYONE EXPERIENCES MIGRAINE DIFFERENTLY. TREATMENT RESULTS MAY VARY.” “However, this 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 of taking the drug. If you have data to support these claims, please submit to FDA for review.”

The video also included other claims noted by the FDA:

• “I have been on handfuls of different prescriptions and over-the-counter medications, and none of them have really worked for me. Or if they worked, and maybe it was a one- or two-time thing and then they didn’t work consistently after that. And I was given Nurtec ODT, I tried it, it was a gamechanger.”
• “So to have this relief, and to not be in a fog afterwards, to not like, other medications would give me rebound headaches, and this one doesn’t ...”

OPDP contended “these comparative claims are misleading because they suggest that Nurtec ODT is clinically superior to or more effective than other prescription and over-the-counter (OTC) products, when this has not been demonstrated. In addition, the use of the word ‘gamechanger’ in the context of the comparative claim misleadingly suggests that Nurtec ODT represents a significant advance over other currently available products, when this has not been demonstrated.”

“While these claims may be an accurate reflection of the spokesperson’s own experience with Nurtec ODT, their personal experience does not support the suggestion that Nurtec ODT is more advanced than or superior to other migraine drug products on the market. FDA is not aware of evidence to support these claims. If you have data to support these claims, please submit to FDA for review,” the Untitled Letter said.

OPDP Contends Video Did Not Communicate Product’s Full Indication of Limitations of Use

OPDP also contended the video was misleading because the interview portion of the video communicated that Nurtec ODT is for the treatment of migraine but it failed to adequately communicate Nurtec ODT’s full FDA-approved indication and limitations of use.

“Specifically, the interview portion of the video fails to convey that Nurtec ODT is approved for the acute treatment of migraine, and that it is not indicated for the preventive treatment of migraine,” the Untitled Letter said.

OPDP noted that although the full indication with limitations of use is presented briefly, at the end of the video, after the interview portion, in a script/text format on the screen, “this does not mitigate the misleading impression.”

The Untitled Letter contended the video was misleading because it failed 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. Specifically, the video contains claims and/or representations about the benefits of Nurtec ODT in the audio portion, while the risk information is presented in text-only format and in small font. Moreover, the risk information only appears briefly for four seconds at the end of the video, after the close of the spokesperson’s presentation, where it is unlikely to draw the viewer’s attention,” the letter said.

OPDP added the video also did not present “any signal to alert the viewer that important risk information follows after the close of the spokesperson’s presentation. In fact, the host of the interview states: ‘we’ll be right back,’ which typically signals the close or end of a presentation. The overall effect of disclosing risk information in this manner undermines the communication of risk information and thereby misleadingly minimizes the risks associated with the use of Nurtec ODT,” the Untitled Letter said.

OPDP requested the company cease any violations of the FD&C Act and submit a written response to the Untitled Letter that listed all other promotional communications for Nurtec ODT with similar representations, along with the FDA Form 2253 submission date, and any plan for discontinuing use of such communications, or for ceasing distribution of the product.

The Untitled Letter noted that Kardashian was identified as a paid Biohaven Pharmaceuticals spokesperson and that the video stated that it was “sponsored by: Nurtec^TM ODT.” OPDP also noted that the FDA Bad Ad Program had received a complaint regarding the video.

Editor’s note: All FDA Warning and Untitled Letters are available in Thompson Information Services’ FDA Enforcement Letter Database, which is available to subscribers of Thompson's FDA Compliance Expert.