Study evaluating atogepant for migraine prevention hits goals

Positive 12-week results from the Phase III ADVANCE trial evaluating atogepant for the preventive treatment of migraine in adults who meet criteria for episodic migraine have been published in the prestigious New England Journal of Medicine (NEJM).

Under development by US drug major AbbVie (NYSE: ABBV), atogepant is currently under review for the prevention of episodic migraines at the US Food and Drug Administration, which has set an action date for an aapproval decision by September.

The study, which enrolled adult participants experiencing four to 14 migraine days per month, found that all active treatment arms of atogepant – 10mg, 30mg, and 60mg once-daily doses – met their primary endpoint of a statistically significant reduction in mean monthly migraine days across the 12-week treatment period compared to placebo.2 The study also found that a greater proportion of atogepant-treated participants achieved at least a 50% reduction in mean monthly migraine days for all doses compared to placebo and met other key secondary endpoints.