MAP Pharmaceuticals initiates PD trial comparing LEVADEX to IV DHE

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that the Company initiated a pharmacodynamics (PD) trial to compare the acute effect of LEVADEX™ orally inhaled migraine therapy to intravenous dihydroergotamine mesylate (IV DHE) and placebo on pulmonary artery pressure as measured by echocardiography. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine. This trial was initiated in support of a planned New Drug Application (NDA) submission for LEVADEX to the U.S. Food and Drug Administration (FDA).

In addition to this trial, the Company is currently conducting an ongoing 12 month open-label safety extension of its Phase 3 FREEDOM-301 trial and a pharmacokinetics (PK) trial in smokers, both of which have completed enrollment. The Company anticipates that all patients will complete treatment this year.  

"We continue to progress our clinical trials for our NDA submission for LEVADEX," said Timothy S. Nelson, president and chief executive office of MAP Pharmaceuticals. "The initiation of this PD trial brings us one step closer to our goal of bringing LEVADEX to many of the approximately 30 million migraine sufferers in the U.S., including those who are not helped by currently available migraine therapies."

This PD trial is a randomized, double blind, placebo controlled, three way, crossover trial in approximately 24 healthy adults and is designed to compare the acute effects of LEVADEX, IV DHE, and placebo on pulmonary artery pressure by taking regular echocardiogram measurements over a two hour period. The trial also will compare the PK of LEVADEX and IV DHE and its metabolites, the effects of both routes of delivery on cardiac function, including echocardiograph findings, 12-lead ECG, and vital signs. In addition, the trial will evaluate the PD and PK of two doses of LEVADEX administered two hours apart as compared to a single dose of 1.0 mg IV DHE.