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MAP0004 is orally inhaled and self-administered at home using MAPPharmaceuticals' proprietary Tempo(R) inhaler. In the company's prior Phase 2efficacy study, MAP0004 provided pain relief in as fast as 10 minutes, withrelief sustained through at least 24 hours. The study also demonstratedefficacy trends in treating nausea, photophobia and phonophobia, the other keymeasurements in treating migraine.
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This randomized, double-blind, placebo-controlled Phase 3 trial isdesigned to evaluate the efficacy and safety of MAP0004 in treating acutemigraine. The primary efficacy endpoints will be pain relief, and freedomfrom nausea, photophobia and phonophobia as measured at two hours afterdosing. MAP will also evaluate earliest onset of pain relief and sustainedrelief to 24 and 48 hours. The multi-center efficacy trial will includeapproximately 850 patients, who will also be followed for 12 months in anopen-label study to confirm long-term safety.
"We believe that MAP0004 has the potential to be a first-line therapy formigraine patients," said Timothy S. Nelson, president and chief executiveofficer of MAP Pharmaceuticals. "Based on our initial clinical studies, webelieve that MAP0004 offers an alternative to triptans that may providepatients with the benefits of rapid onset and long-lasting pain relief, in aneasy-to-use, non-invasive, at-home therapy. In our Phase 2 trials, MAP0004was well tolerated with no effect on pulmonary function, including inasthmatic subjects."
The therapeutic agent in MAP0004 is dihydroergotamine (DHE), which has along history of use as a safe and effective migraine treatment. Many headachespecialists consider DHE administered by injection to be the standard of carein treating chronic migraine and debilitating migraines that last more than 72hours. MAP Pharmaceuticals is seeking to expand the use of this compound totreat migraines early, non-invasively and with a fast onset of action.
MAP Pharmaceuticals is initiating the first Phase 3 trial of its MAP0004product candidate pursuant to a Special Protocol Assessment (SPA) with theU.S. Food and Drug Administration. The SPA is intended to provide assurancethat if pre-specified trial results are achieved, they may serve as theprimary basis for an efficacy claim in support of a new drug application. Ingeneral, these assessments are considered binding on the FDA as well as thesponsor unless public health concerns unrecognized at the time the SPA isentered into become evident or other new scientific concerns regarding productsafety or efficacy arise.
About Migraine
Migraine is a common, debilitating neurological disease affectingapproximately 30 million people in the United States. It presents withrecurrent attacks of headaches, nausea, vomiting and sensitivity to light andsound. Most migraines last between four and 24 hours, but some last as longas three days. On average, migraine sufferers experience 1.5 migraine attacksmonthly, although 25 percent of them experience one or more attacks weekly.
In published studies, migraine sufferers often cite faster onset of painrelief and lower incidence of migraine recurrence as two key therapeuticattributes they would like from their medication. Currently approved drugsfor the treatment of an acute migraine attack do not fully meet the needs ofall patients due to the slow onset of action, short duration of effect,inconsistent response, unacceptable side effect profiles, or propensity toincrease frequency of headaches with these therapies.
In 2007, triptans, the class of drugs most often prescribed for treatingmigraine, generated sales of approximately $2.2 billion in the United States,according
