AbbVie's oral migraine prophylaxis Aquipta (atogepant) met its primary endpoint in a phase 3 clinical trial of patients who failed prior oral prophylaxis, reducing the average number of migraine days per month.

AbbVie Korea said Friday that the full results of the phase 3 ELEVATE study were published in Lancet Neurology on Feb. 13.

AbbVie Korea said the study met its primary and secondary endpoints and demonstrated a statistically significant reduction in mean migraine days per month (MMD) in patients with episodic headaches treated with once-daily oral Aquipta 60 mg compared to placebo.

In the ELEVATE study, AbbVie evaluated the efficacy of Aquipta vs. placebo for preventing episodic headaches in patients who had failed two to four prior oral preventive treatments. Of the 309 patients enrolled, 56 percent had failed two prior oral preventive treatments, and 44 percent had failed three or more prior treatments.

The main reasons for discontinuation were lack of efficacy or tolerability.

The primary endpoint was the change from baseline in mean migraine days per month over 12 weeks, and secondary endpoints included a 50 percent or more reduction in migraine days per month over 12 weeks, a change from baseline in migraine days per month, and acute medication days.

Results showed that MMD decreased by 1.9 days from baseline in the placebo group, compared to 4.2 days over the 12-week treatment period in patients treated with Aquipta 60 mg orally once daily (p<0.0001).

Overall safety data results were consistent with the known safety profile of Aquipta, with the most commonly reported (≥5 percent in all dosing groups) treatment-emergent adverse events (TEAEs) being constipation, Covid-19, nausea, and nasopharyngitis.

Aquipta is an oral CGRP receptor antagonist developed for the preventive treatment of migraines in adults, and it received approval from the Ministry of Food and Drug Safety last November. It is reportedly preparing for a domestic launch this year.

"Migraine has a significant impact on the lives of patients and their families. In particular, the experience of failing multiple preventive treatments can be a serious burden," said Ryu Eun-jin, head of the Medical Department at AbbVie Korea. “New treatment options effective in preventing episodic and chronic migraine in people who have failed other treatments will contribute to improving the lives of patients and their families."