Ubrogepant

Tonix is set to launch a disease education website to explain the link between gastroparesis and migraine. Tonix Pharmaceuticals is trying to start a conversation about a potential shortcoming of oral migraine drugs, kicking off a national campaign to raise awareness of a condition that can affect absorption.The company’s commercial subsidiary, Tonix Medicines, markets two formulations of sumatriptan for use in migraine. Sumatriptan was approved more than 30 years ago. Dr. Reddy’s Laboratories received FDA approval for an injectable formulation, Zembrace SymTouch, in 2016 and a nasal spray version in 2019. Tonix acquired the products in 2023.Facing off against oral drugs such as AbbVie’s Ubrelvy, Tonix is seeking to raise awareness of potential benefits of nasal and injectable formulations with the “Does Your Migraine Pill Work Every Time?” Tonix launched the campaign at the PAINWeek 2024 National Conference in Las Vegas.The question posed in the educational campaign reflects studies showing a link between gastroparesis and migraine. Gastroparesis is defined by the delayed emptying of the contents of the stomach into the intestine, potentially causing symptoms such as vomiting. Studies show some patients have migraine and gastroparesis at the same time. If that happens, gastroparesis could limit the absorption of oral drugs. “Non-oral migraine medications, such as injectables and nasal sprays, do not rely on the digestive system to be absorbed and can offer the potential for faster relief from migraine symptoms in as little as 10 minutes,” the University of Texas Southwestern Medical Center’s Deborah Friedman, M.D., said in a statement. Friedman encourages patients and doctors to discuss adding non-oral options to their treatment plans.Tonix is set to launch a disease education website to explain the link between gastroparesis and migraine and why oral medicines may not work. The company has also scheduled a webinar on the topic for next week.Spreading the word about situations in which oral drugs may be ineffective could benefit Tonix’s drugs, sales of which totaled $2.2 million in the second quarter. The figure makes Tonix a small player in the migraine market. Pfizer reported $356 million in sales of Nurtec ODT, which dissolves in the mouth, over the same period. AbbVie’s Ubrelvy and Qulipta generated a combined $381 million.

Serena Williams The FDA has faulted AbbVie’s promotion of the migraine drug Ubrelvy, calling the company out for an ad featuring Serena Williams that went out of bounds with claims about how quickly the product relieves symptoms.AbbVie received details of the FDA’s grievances in an untitled letter about the “When Migraine Strikes” TV spot it began running in support of Ubrelvy last year. The ad opens with tennis star Serena Williams in a talk show dressing room. Williams shows signs of suffering a migraine, putting her hand to her head and recoiling from a bright light.In voice-over, Williams says the options when a migraine strikes are “ride it out with the tradeoffs of treating” or “push through the pain and symptoms.” Ubrelvy, Williams tells us, provides another option. “One dose works fast to eliminate migraine pain,” the tennis legend says.The speed at which Ubrelvy acts is at the center of the FDA’s concerns with the ad. After saying Ubrelvy works fast, Williams is shown laughing and smiling and walking happily onto a brightly lit talk show stage. “This compelling before-and-after presentation in conjunction with claims such as, ‘One dose works fast to eliminate migraine pain’ and ‘UBRELVY QUICKLY ELIMINATES MIGRAINE PAIN’ misleadingly suggests that Ubrelvy eliminates migraine pain and symptoms more quickly than was demonstrated in the clinical trials,” the FDA said.The FDA notes the storyboard submitted for review said the opening scene in the dressing room takes place in the afternoon, and the shots of Williams “doing a final check in the mirror” before the talk show are in the evening. However, the administration said the finished ad “does not portray the passing of time in a manner that is consistent with the description in the storyboard.”That is a problem, because the Ubrelvy label outlines the drug’s effect on pain and other symptoms two hours after dosing. AbbVie included small text in the ad to clarify that “some people had pain freedom within 2 hours,” but the FDA found that caveat was “not sufficient to mitigate this misleading suggestion that Ubrelvy can eliminate migraine pain and symptoms more quickly than has been demonstrated.”The FDA also called AbbVie out for the statement “one dose works fast to eliminate migraine pain.” In the Ubrelvy clinical trials, about one-fifth of participants were free from pain two hours after taking one dose of the drug. Again, the FDA ruled that the clarifying text was insufficient to correct the misleading impression. The FDA raised specific concerns about making misleading statements in a celeb-led ad. “The use of a celebrity athlete in this TV ad amplifies the misleading representations and suggestions made and increases the potential for audiences to find the misleading promotional communication more believable due to the perceived credibility of the source,” the FDA said.AbbVie acquired Ubrelvy in its takeover of Allergan. The untitled letter states the FDA sent advisory comments to Allergan in 2020. The comments are redacted, but the FDA did publish its concerns that AbbVie “appears to be promoting Ubrelvy using similar claims and presentations in a misleading manner.”