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The intermittent use of ubrogepant, 1 or 2 doses
per attack of migraine found to be well tolerated with a low incidence of
serious adverse events.
A recent phase 3 randomized trial found that the long-term intermittent use of 50 mg and 100 mg ubrogepant is safe and well-tolerated in patients with acute migraine. This was an open-label, multicenter 52‐week extension trial, in which adults with migraine with or without aura entered the trial after completing one of 2 phase of 3 lead‐in trials. The primary outcomes were safety and tolerability.
The 1230 patients with an average age of 42 years from the 3 trials were re‐randomized as 404 to ubrogepant 50 mg, 409 ubrogepant 100 mg and 417 to usual care. The patients in the usual care group used their own medicines to get relief from migraine.
On the whole 21,454 migraine attacks were treated with 31,968 doses of ubrogepant. The most common treatment‐emergent adverse events (TEAE) was upper respiratory tract infection which was observed in 268/404 (66%) patients of ubrogepant 50 mg group, 297/409 (73%) patients of ubrogepant 100 mg. Only 10% of participants with TEAEs were considered significantly related to the treatment by the study investigator.
Serious adverse event (SAE) observed was sinus tachycardia in 9/404 (2%) patients of ubrogepant 50‐mg group and 12/409 (3%) patients of ubrogepant 100‐mg group.
Overall, data from this phase 3, 52-week extension trial further supports the safety profile of ubrogepant.
Headache
Long‐Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52‐Week Extension Trial
Jessica Ailani et al.
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