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| |  Novel Inhaled Therapy Effective, Well-Tolerated in Patients With Resistant Migraines: Presented at IHS/AHS By Liz Meszaros PHILADELPHIA -- September 12, 2009 -- A novel inhaled therapy, MAP0004, offers patients with resistant migraine rapid and sustained pain relief with minimal adverse effects, according to a study presented here at the 14th Congress of the International Headache Society & the 51st Annual Scientific Meeting of the American Headache Society (IHS/AHS). MAP0004 is an orally inhaled form of dihydroergotamine that can be self-administered by the patient using a novel inhaler. Shashidhar H. Kori, MD, MAP Pharmaceuticals, Mountain View, California, presented the results of the multicentre, phase 3 trial on September 11. The study included patients aged 18 to 65 years who had experienced International Headache Society-defined migraines for 1 year, had 2 to 8 headaches per month, had 20 headache-free days in the last 28 days of the run-in period, and had a predicted forced expiratory volume in the first second of expiration >= 50%. Patients were randomised to MAP0004 (n = 911) or placebo (n = 792). The study drug met all 4 coprimary efficacy endpoints of the study compared with placebo: pain relief at 2 hours (59% vs 35%, respectively; P < .0001); patients who were photophobia free at 2 hours (47% vs 27%; P < .0001); patients who were phonophobia free at 2 hours (53% vs 34%; P < .0001); and patients who were nausea free at 2 hours (67% vs 59%; P = .0210). Compared with placebo, MAP0004 was also effective in providing pain relief starting as early as 30 minutes (29% vs 22%; P = .0266) and sustained from 2 to 24 hours (44% vs 20%; P < .0001). MAP0004 was effective in providing pain relief from 2 to 48 hours compared with placebo (36% vs 17%; P < .0001, not adjusted for multiplicity). Indication of taste was the most common adverse event seen with MAP0004 compared with placebo (6% vs 2%, respectively), with nausea being the second most common (4.5% vs 2%). Rates of upper respiratory tract infection, nasopharyngitis, and sinusitis were similar between the treatment and placebo groups, and during the run-in phase. Symptoms and sensitivities that are typically associated with triptan therapy, including chest discomfort, chest pain, and paresthesia were rare with MAP0004 and comparable to those seen with placebo. “We’ve taken a drug that is probably the most extensively used for any kind of resistant migraine -- whether it’s chronic daily headache, chronic migraine, status migrainosus, and so on -- a drug that has been proven to be highly effective for most resistant migraines, and made it easier to administer, with a very fast response rate, and a significantly reduced rate of side effects, including nausea and dizziness,” said Dr. Kori. [Presentation title: Efficacy and Tolerability of MAP0004, A Novel Inhaled Therapy, in Treating Acute Migraine. Abstract PO04]
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