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
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