MAP initiates Ph III migraine drug trials

California, USA-based MAP Pharmaceuticals has initiated a Phase III clinical program to evaluate MAP0004 as a potential treatment for migraine. The orally-inhaled agent is self-administered at home using MAP's proprietary Tempo inhaler.

The firm noted that, in a prior Phase II efficacy study, MAP0004 provided pain relief in as little as 10 minutes, with relief sustained through at least 24 hours. The study also demonstrated efficacy trends in treating nausea, photophobia and phonophobia, the other key measurements in treating migraine.

This randomized, double-blind, placebo-controlled Phase III trial is designed to evaluate the efficacy and safety of MAP0004 in treating acute migraine. The primary efficacy endpoints will be pain relief and freedom from nausea, photophobia and phonophobia as measured at two hours after dosing.