MAP Pharmaceuticals to present FREEDOM-301 Phase 3 trial data for migraine at EHMTIC Congress

Oct 29 2010

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced new data from the FREEDOM-301 Phase 3 trial of its investigational LEVADEX™ orally inhaled migraine therapy showing low recurrence rates with LEVADEX. Eight additional analyses from the LEVADEX program also will be presented during the 2010 European Headache and Migraine Trust International Congress (EHMTIC) in Nice, France.  

Physicians commonly use the term recurrence to assess the sustained action of a migraine drug. However, there is not a standard definition of recurrence, and different methods are used in the clinical setting to calculate recurrence rates. This analysis calculated recurrence rates using four different definitions from the literature to illustrate the variability of using this endpoint for comparing different migraine treatments.

"Recurrence rate is one of the main attributes that physicians rely on to assess the sustained effects of acute migraine therapies.  However, the way in which recurrence is defined can vary widely," said Shashidhar H. Kori, M.D., Vice President, Clinical Development and Medical Affairs of MAP Pharmaceuticals. "While a standard definition would help make these comparisons more meaningful, data from this analysis showed low recurrence rates with LEVADEX regardless of the definition used."

In the poster titled "Migraine Recurrence Rates: Case for Standardization of the Definition," LEVADEX had a low recurrence rate at both 24 and 48 hours irrespective of the definition used. Two large meta-analyses have calculated the cumulative recurrence rate for triptans to be 22 percent and 29 percent over 24 hours. Using the same definition, this analysis found LEVADEX to have a recurrence rate of 6.5 percent over 24 hours and 10.3 percent over 48 hours. No 48 hour recurrence data was reported in the triptan analyses. Factors found to affect the rate of recurrence in the triptan meta-analyses include gender of the patient, age group (below 35 and above 35), and severity of headache pain at the time of treatment (moderate vs. severe). In this analysis, both age and severity of pain at time of treatment were associated with higher recurrence rates in the placebo group.

A second new analysis, "The Major Metabolite of Dihydroergotamine (DHE) After Oral Inhalation and IV Administration Does Not Significantly Contribute to the Pharmacological Activity," analyzed results of two studies and showed that the pharmacologic contribution of DHE's primary metabolite is minimal.

The seven other analyses to be presented include:

• LEVADEX, a Novel Orally Inhaled Treatment for Acute Migraine: Efficacy and Tolerability Results of a Phase 3 Study (#462)
• Efficacy Evaluation of LEVADEX in Treating a Broad Spectrum of Acute Migraine Attacks (#463)
• Efficacy Evaluation of LEVADEX in Treating Resistant Migraine Including Migraine with Allodynia, Morning Migraine, Disabling Migraine and Migraine Treated Late (#464)
• Utility of LEVADEX in Situations Where Early Intervention Paradigm is Impractical (#322)
• Evaluation of Safety and Efficacy of LEVADEX (MAP0004) in Treating Acute Menstrual Migraine (#465)
• Evaluation of Efficacy and Safety of LEVADEX (MAP0004) in Reversing Central Sensitization and Treating Migraine in Established Allodynic Patients (#466)
• The Efficacy and Tolerability of LEVADEX (Orally Inhaled DHE) for the Treatment of Migraine in Subjects with Concomitant Asthma (#467)