MAP0004 for the Treatment of Severe Pain Associated with Migraine

Data presented at the 2013 AAN Annual Meeting indicate that MAP0004, which delivers dihydroergotamine (DHE) via oral inhalation, is effective in the acute treatment of severe migraine pain.

In “Efficacy of MAP0004 in Treating Severe Migraine Pain,” Kori and colleagues performed a post-hoc analysis of subjects with severe migraine pain at the time of treatment during the double-blind period of a Phase 3 clinical trial to assess the efficacy of MAP0004 in treating severe migraine pain. MAP0004, which “delivers dihydroergotamine (DHE) systemically via oral inhalation,” has been shown to be superior to placebo for the acute treatment of migraine in previous studies. The researchers “examined migraine pain relief, pain free, sustained pain relief, sustained pain free and recurrence endpoints as reported by subjects who had severe migraine pain at the time of treatment” in a randomized trial of MAP0004.

They reported that 46% of patients (366 of 794 participants) experienced severe migraine pain. Patients with severe migraine pain treated with MAP0004 experienced “statistically significant pain relief compared to placebo (p<0.05) at 10 minutes and at all subsequent time points studied.” More patients treated with MAP0004 were pain free at 60 minutes, compared to placebo, and at all subsequent time points. Patients treated with MAP0004 also reported higher rates of sustained pain relief and complete elimination of pain over 24 and 48 hours, compared to placebo. Only 6.2% of patients treated with MAP0004 reported headache recurrence over 24 hours, compared to 18% of patients who received placebo.

The authors concluded that this analysis “indicates that MAP0004 was effective in the acute treatment of severe migraine pain in the Phase 3 clinical trial.”

Kori and colleagues also reported, in “Consistency of Migraine Pain Relief after Repeated Administration of MAP0004,” the results of a post-hoc analysis of whether “pain relief rates were consistent across a sequence of migraines treated with MAP0004” in a Phase 3 clinical trial. This study “included subjects enrolled in the MAP0004 cohort of an open-label safety study who experienced at least 25 qualifying migraines (QMs).” Researchers compared pain relief, pain free, sustained pain relief, and sustained pain free endpoints between QMs 1, 5, 15, and 25 in 153 patients.

More than half of subjects (51%) reported pain relief at two hours after their first QM. The authors reported “no statistically significant difference” in the percentage of patients who reported pain relief at two hours for each subsequent migraine. There was also no significant difference “when comparing across the four migraines.” Slightly more than 20% of patients reported being pain free at two hours after the first QM, 36.6% reported sustaind pain relief for 2-24 hours after first QM, and 15% reported sustained total pain relief for 2-24 hours after the first QM, rates that were not statistically different when comparing across QMs 1, 5, 15, and 25.

Based on this analysis, the athours reported that “MAP0004 provided consistent migraine pain relief for the 1st, 5th, 15th or the 25th QM assessed over approximately one year.”