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MAP Pharmaceuticals Reaches Agreement with FDA on Special Protocol Assessment for MAP0004 Phase 3 Clinical Trial in Patients With Migraine
Date:1/16/2008

atients prefer migraine therapies providing fast onset, pain relief, sustained pain relief and safety, the company believes that MAP0004 has the potential to be a first-line therapy for migraine patients. Historically, estimated onset of significant pain relief with oral triptans, the class of drugs most often prescribed for treating migraine, occurs between 45 and 90 minutes after dosing. In 2006, triptans generated sales of approximately $2.1 billion in the United States, according to data published by IMS Health.

MAP0004 is designed to be an easy to use, non-invasive, at-home therapy that patients self-administer using the company's proprietary hand-held Tempo(TM) inhaler. DHE is currently available as an intravenous therapy which has been used in clinical settings for over 50 years for the safe and effective treatment of migraine, but requires healthcare intervention for administration. In the company's Phase 2 clinical efficacy study, MAP0004 was shown to retain the rapid onset and long-lasting effectiveness of intravenous DHE while avoiding the nausea that intravenous administration can cause.

About Migraine

Migraine is a common, debilitating neurological disease affecting approximately 30 million people in the United States. It presents with recurrent attacks of headaches, nausea, vomiting and sensitivity to light and sound. Most migraines last between four and 24 hours, but some last as long as three days. On average, migraine sufferers experience 1.5 migraine attacks monthly, although 25% of them experience one or more attacks weekly. Currently approved drugs for the treatment of an acute migraine attack do not fully meet the needs of all patients due to the slow onset of action, short duration of effect, inconsistent response, unacceptable side effect profiles, or propensity to increase frequency of headaches with these therapies.

About Special Protocol Assessment

During the Special Protocol Assessment (SPA) process, the
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SOURCE MAP Pharmaceuticals, Inc.
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