MAP Pharmaceuticals Reaches Agreement with FDA on Special Protocol Assessment for MAP0004 Phase 3 Clinical Trial in Patients With Migraine

MAP Pharmaceuticals, Inc. , an emerging pharmaceutical company, today announced that it has completed the special protocol assessment (SPA) process with the U.S. Food and Drug Administration (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.

Source : money.cnn.com