Presented at the 2013 AAPM Annual Meeting « Back

Efficacy of MAP0004 in Treating Severe Migraine Pain

Emilee Connors, PhD, econnors@mappharma.com¹, Shashidar Kori¹, Jay Zhou, MBA¹, Biao Lu, PhD1, Scott Borland¹, (1) MAP Pharmaceuticals, Mountain View, California

Introduction: The treatment needs of migraine patients are often unmet by available therapies. Severe migraines, in particular, have been shown to be more difficult to treat. MAP0004, an investigational product candidate which delivers dihydroergotamine (DHE) systemically via oral inhalation, was superior to placebo for the acute treatment of migraine in a Phase 3 trial. A post-hoc analysis of subjects with severe migraine pain at the time of treatment during the double-blind period was performed to assess the efficacy of MAP0004 in treating severe migraine pain. The study design (and primary results) for the double-blind portion of the trial, the basis for this post-hoc analysis, was previously published. Severe migraine pain was reported by 366 of the 794 trial subjects. Subjects with severe migraine pain receiving MAP0004 experienced statistically significant pain relief compared to placebo (p<0.05) at 10 minutes and at all subsequent time points studied. Significantly more subjects with severe migraine pain who received MAP0004 were pain free (p<0.05) compared to placebo at 60 min and at all subsequent time points. Sustained pain relief and sustained pain free, both between 2-24 and 2-48 hr, were statistically significantly higher for MAP0004 recipients relative to placebo. Headache recurrence over 24 hr occurred in 6.2% of subjects with severe migraine pain receiving MAP0004 as compared with 18% for placebo. This post-hoc analysis shows that MAP0004 was effective in the acute treatment of severe migraine pain in a Phase 3 trial. References: 1) Aurora SK, Silberstein SD, Kori SH, et al. MAP0004, Orally Inhaled DHE: A Randomized, Controlled Study in the Acute Treatment of Migraine (301). Headache. 2011; 51: 507-517.

Funding: Study supported by MAP Pharmaceuticals, Inc.