Data from FREEDOM-301 Study for LEVADEXâ„¢ Orally Inhaled Migraine Drug Published in 'Headache'
MOUNTAIN VIEW, Calif., April 7, 2011 /PRNewswire/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced the publication of results from the Phase 3 FREEDOM-301 study of LEVADEX™ orally inhaled migraine drug in the peer-reviewed journal 'Headache.' The manuscript, titled MAP0004, Orally Inhaled DHE: A Randomized, Controlled Study in the Acute Treatment of Migraine, has been posted online and will appear in the April edition, Volume 51, Issue 4 of Headache: The Journal of Head and Face Pain. LEVADEX is an investigational acute therapy for migraine that has completed Phase 3 clinical development.
"There is general dissatisfaction with existing acute treatment options for migraine because of slow onset of action, inadequate pain relief, and high recurrence rates. Based on the results from the FREEDOM-301 study, LEVADEX has the potential to address many of the unmet needs of migraine sufferers," said Sheena Aurora, M.D., a FREEDOM-301 clinical study investigator, director of the Swedish Headache Center and assistant professor of neurology at the University Of Washington School of Medicine.
In the FREEDOM-301 study, the efficacy assessment focused on the four major symptoms of migraine at the standard two hour time point for acute migraine studies. All four co-primary endpoints for LEVADEX were met at two hours:Pain relief was observed in 59% of patients in the LEVADEX treatment group compared with 35% in the placebo group (p<0.0001) Phonophobia free was observed in 53% of patients in the LEVADEX treatment group compared with 34% for the placebo group (p<0.0001) Photophobia free was observed in 47% of patients in the LEVADEX treatment group compared with 27% for the placebo group (p<0.0001) Nausea free was observed in 67% of patients in the LEVADEX treatment group compared with 59% for the placeb