Zavegepant Treatment Results in Rapid Pain Relief of Migraine Within 15 Minutes

In clinical trials, intranasal zavegepant (Biohaven, New Haven, CT) demonstrated statistically significant superiority vs placebo on a total of 15 consecutive outcome measure in the acute treatment of migraine. Zavegepant treatment resulted in pain relief at the earliest measured time point of 15 minutes and sustained efficacy through 48 hours after a single intranasal dose. A new drug application is being prepared for submittion to the Food and Drug Administration (FDA).

Richard B. Lipton, MD, professor and vice chair of Neurology at the Albert Einstein College of Medicine and director of the Montefiore Headache Center, said "Patients with migraine rate speed of onset (among) the most important aspects of an effective therapy. The data from this trial shows that intranasal zavegepant delivered impressive performance on this metric by demonstrating statistically significant pain relief within 15 minutes and return to normal function within 30 minutes. Additionally, nonoral treatments offer additional benefits for patients who experience nausea, vomiting, or gastroparesis (with slow absorption). Intranasal zavegepant will be an important new treatment option for patients who require a rapid and nonoral option for acute treatment of their migraine attacks."

Zavegepant was statistically superior to placebo for pain freedom (24% vs 15%, P<.0001) and freedom from most bothersome symptom (40% vs 31%, P=.0012) at 2 hours. Participants achieved return to customary function as early as 30 minutes after dosing (P<.006). The efficacy benefits of zavegepant were durable, including superiority vs placebo (P<.05) on: sustained pain freedom 2 to 24 hours, sustained pain freedom 2 to 48 hours, sustained pain relief 2 to 24 hours, and sustained pain relief 2 to 48 hours. 

This phase 3 pivotal study was a randomized double-blind placebo-controlled clinical trial in 1,405 participants with at least a 1-year history of migraine (with or without aura) and migraine attacks lasting 4 to 72 hours when left untreated. The study evaluated a single dose of intranasal zavegepant vs placebo for the acute treatment of a moderate-to-severe migraine attack. 

Zavegepant showed a favorable safety and tolerability profile among study participants that was consistent with prior clinical trial experience. The most common adverse event reported was abnormal taste (21% vs 5%).