At this time, MAP0004 is in Phase III clinical trials 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. MAP will also evaluate earliest onset of pain relief and sustained relief to 24 and 48 hours. The multi-center efficacy trial will include approximately 850 patients, who will also be followed for 12 months in an open-label study to confirm long-term safety.
If trials go as expected, MAP0004 has the potential to be a first-line therapy for Migraine patients, and has the potential to treat patients who have not previously responded to other therapies, such as triptans.
Summary and comments:
Results of MAP0004 trials to date indicate that taking another look at new ways to utilize older medications can be time well spent. Certainly, Migraineurs look forward to having a new and effective tool to add to our arsenal as current options leave many Migraineurs out in the cold when it comes to abortives.
“Currently approved drugs for the treatment of an acute migraine attack do not fully meet the needs of all patients due to their slow onset of action, short duration of effect, inconsistent response, unacceptable side effect profiles, or even propensity to increase frequency of headaches with these therapies. We believe that MAP0004 may offer a solution to many of these limitations associated with current therapies.”
Timothy S. Nelson
President and CEO of MAP Pharmaceuticals
Certainly, we all look forward to medications that work more quickly, provide longer sustained relief, and have a lower incidence of side effects.
"In one of our Phase 2 efficacy studies presented last year, MAP0004 provided pain relief in as fast as ten minutes, with relief, in many patients, 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. MAP0004 was well tolerated, with no serious adverse events reported, in our Phase 2 studies. Drug-induced nausea was low and migraine-associated nausea also decreased with treatment. Another study indicated that MAP0004 was also well tolerated by subjects with compromised lung function, which is important since asthma and migraine have a high incidence of co-morbidity."
Dr. Shashidhar H. Kori
Vice President of Clinical Development
