MAP Pharma publishes LEVADEX Phase 3 FREEDOM-301 study data in 'Headache' journal

Apr 7 2011

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 placebo group

Four prospectively defined secondary endpoints also were analyzed:

• Sustained pain relief from two to 24 hours was observed in 44% of patients in the LEVADEX treatment group compared with 20% for the placebo group (p<0.0001)
• The statistically significant time to pain relief was calculated to be 30 minutes
• Pain relief at four hours was observed in 65% of patients in the LEVADEX treatment group compared  with 37% for the placebo group (p<0.0001)
• The proportion of patients experiencing pain relief at 10 minutes, while not statistically significant, was 50% greater in the LEVADEX treatment group (9%) compared with the placebo group (6%)

LEVADEX was well tolerated, with no drug-related serious adverse events reported during the study. The most common adverse events reported were medication aftertaste (6%) and nausea (5%), both compared to 2% for placebo. Triptan sensations such as chest discomfort (1%), chest pain (0%) and paresthesias (0.5%) were rare in patients treated with LEVADEX and comparable to placebo.

"We are pleased to have our Phase 3 data published in 'Headache.' These data are part of a comprehensive clinical program that evaluated LEVADEX in approximately 1,000 patients, treating nearly 10,000 migraines," said Donald J. Kellerman, MAP Pharmaceuticals' Senior Vice President, Clinical Development and Medical Affairs. "We look forward to submitting our NDA for LEVADEX for the acute treatment of migraine in the first half of 2011 and, if approved by the FDA, moving one step closer to our goal of providing the migraine patient population with a new treatment option."