MAP Reaches Agreement With FDA On MAP0004 Clinical Trial In Patients With Migraine
MAP Pharmaceuticals has completed the special protocol assessment (SPA) process with FDA for the first Phase 3 clinical trial of its MAP0004 product candidate, and has reached agreement with the Agency on the design of the protocol. The study, if successful, could support the potential approval of MAP0004 as a treatment for migraine.
"Following the positive results we saw in our Phase 2 trials, we are pleased to now have agreement with the FDA on the protocol for our first Phase 3 clinical trial to evaluate MAP0004 in migraine," stated Stephen Shrewsbury, M.B., Ch.B., Chief Medical Officer of MAP Pharmaceuticals. "We look forward to initiating this trial in early 2008."
This multi-center Phase 3 trial will include a randomized, double blind, placebo-controlled component to evaluate the efficacy and safety of MAP0004 in treating a single acute attack of migraine in approximately 850 patients followed by a 12-month open-label safety assessment. The primary efficacy endpoints will be pain relief at two hours, and freedom from nausea, photophobia and phonophobia at two hours.
MAP0004 is a proprietary orally inhaled version of dihydroergotamine, or DHE, intended to treat migraine. The company's Phase 2 efficacy study showed that MAP0004 provided pain relief as early as within ten minutes of dosing, and that this relief was sustained through at least 24 hours. The study also demonstrated efficacy trends in treating nausea, photophobia and phonophobia. Based on these results, as well as independent research that concludes that patients 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 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.
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.