(RTTNews) - AbbVie (ABBV) said that the Phase 3 ADVANCE trial evaluating the investigational medicine atogepant, an orally administered calcitonin gene-related peptide receptor antagonist or gepant met its primary endpoint of statistically significantly greater reduction in mean monthly migraine days, compared to placebo, for all doses across the 12-week treatment period.
The trial also demonstrated statistically significant improvements in all six secondary endpoints in the 30 mg and 60 mg once-daily treatment arms.
The company said it plans to move forward with regulatory submissions in the United States and other countries, based on the data from the trial and previous Phase 2/3 trial.
The company noted that the results support its commitment to providing multiple treatment options, including BOTOX (onabotulinumtoxinA) for the prevention of chronic migraine and UBRELVY (ubrogepant), to treat migraine.
Migraine is a complex, chronic disease with episodic attacks that are often incapacitating and characterized by headache pain as well as neurologic and autonomic symptoms.
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