MAP REPORTS FINDINGS FROM TRIAL OF INHALED MIGRAINE DRUG

Map Pharmaceuticals announced that its Tempo Migraine drug candidate met the primary endpoints in a Phase II clinical program consisting of two separate trials. The candidate is a proprietary orally inhaled formulation of dihydroergotamine.

The first Phase II study demonstrated clinically significant results in a randomized, placebo-controlled study at nine U.S. headache centers. In addition, a second Phase II clinical trial indicated that Tempo Migraine was well tolerated by subjects with impaired pulmonary function.

In the first study, Tempo Migraine showed statistically significant pain relief at two hours and sustained pain relief at 24 hours compared with placebo in the treatment population. In addition, the drug demonstrated statistically significant pain relief at 10 minutes. While this study was powered on pain relief, it showed clinically significant trends in the resolution of phonophobia, photophobia and nausea, reaching statistical significance at certain time points. Furthermore, Tempo Migraine demonstrated statistically significant total migraine relief versus placebo at 60 minutes and sustained relief at 24 hours for subjects receiving treatment.

The second Phase II study was carried out to evaluate pulmonary delivery of the drug in adults with compromised pulmonary function. The study was a randomized, double-blind, placebo-controlled, crossover study of Tempo Migraine in adult asthmatics. The trial demonstrated that the therapy was well tolerated by asthmatics, with no serious adverse events reported.

Map is developing a series of inhaled respiratory and systemic drug products delivered with the Tempo platform. In early human studies, Tempo Migraine delivered therapeutic blood levels within minutes of inhalation, similar to those seen after intravenous injection.