MAP0004, Orally Inhaled Dihydroergotamine for Acute Treatment of Migraine: Efficacy of Early and Late Treatments

OBJECTIVE: To evaluate the efficacy of MAP0004, an orally inhaled dihydroergotamine, for acute treatment of migraine when administered at various time points from within 1 hour to more than 8 hours after migraine onset. PATIENTS AND METHODS: This post hoc subanalysis was conducted using data from 902 patients enrolled in a randomized, double-blind, placebo-controlled, 2-arm, phase 3, multicenter study conducted from July 14, 2008, through March 23, 2009. End points were 2-hour pain relief and pain-free rates In patients who treated a migraine in <= 1 hour, from > 1 hour to <= 4 hours, from > 4 to <= 8 hours, or in > 8 hours after onset of migraine, given that patients may be unwilling or unable to Initiate treatment at headache inception. RESULTS: Treatment with MAP0004 was significantly more effective than placebo In relieving pain at all treatment points (<= 1 hour after start of migraine: 66% [74/112] for MAP0004 vs 41% [48/118] for placebo, P <.001; > 1 to <= 4 hours: 60% [91/153] vs 35% [58/168], P <.001; > 4 to 58 hours: 53% [36/68] vs 30% [16/54], P=.008; and > 8 hours: 48% [25/52] vs 24% [11/46], P=.007). Pain-free rates were also significantly higher with MAP0004 than placebo for treatment within 8 hours after migraine onset (<= 1 hour: 38% [43/112] for MAP0004 vs 13% [15/118] for placebo, P <.001; > 1 to <= 4 hours: 28% [43/153] vs 10% [17/168], P <.001; > 4 to <= 8 hours: 22% [15/68] vs 7% [4/54], P <.025) but not at > 8 hours (19% [10/52] vs 9% [4/46], P=.106). CONCLUSION: This post hoc subanaiysis shows that MAP0004 was effective In treating migraine irrespective of the time of treatment, even more than 8 hours after onset of migraine pain.