AbbVie’s menstrual-migraine study meets its primary and all ranked secondary goals

AbbVie ($ABBV) reported positive Phase 3 LUNA results for atogepant in menstrual migraine. The study enrolled 468 women and evaluated treatment across three menstrual cycles. Migraine days during the assessed menstrual period fell by 1.20 days with atogepant versus 0.40 days with placebo, producing a statistically significant 0.80-day difference on the primary measure.

The trial also met all eight ranked secondary endpoints, and AbbVie said no new safety signals were identified. The company plans to use the results in discussions and submissions to regulators across markets. The findings support a potential expansion of the medicine’s role in migraine care, but do not themselves establish approval for the new indication. The reported benefit is a comparison with placebo in this study, not evidence of superiority over another active migraine treatment.

Sources:

• AbbVie — LUNA Phase 3 results, PR Newswire