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