Analysis of subjects with menstrually related migraine vs. Non-menstrually related migraine treated with MAP0004

Abstract

Menstrually related migraine (MRM) is defined as occurring from days -2 to +3 of menstruation in at least 2 out of 3 menstrual cycles, and additionally at other times of the menstrual cycle. MRM is generally longer lasting, more severe, and more difficult to treat compared to non-MRM attacks. MAP0004 is an investigational orally inhaled dihydroergotamine (DHE) for the acute treatment of migraine. In a large Phase 3 study, MAP0004 was effective and well tolerated in treating an acute migraine attack compared to placebo. This post-hoc analysis compares the efficacy of MAP0004 in treating MRM versus non-MRM, including an analysis of recurrence rates using 4 different, previously published recurrence rate definitions. The efficacy of MAP0004, as measured by pain relief at 2 hours, pain free at 2 hours, sustained pain relief at 2-24 and 2-48 hours, and sustained pain free at 2-24 and 2-48 hours values, was not significantly different between subjects with MRM and non-MRM. Furthermore, the MRM recurrence rates after pain relief were not statistically higher than that of non-MRM treated with MAP0004. There were no significant differences in the frequency of adverse events for MRM vs. non-MRM subjects, and no drug-related serious adverse events were reported. In the study, MAP0004 was effective and well-tolerated for both MRM and non-MRM.