MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today reported results from a pharmacodynamics (PD) trial comparing the acute effects on pulmonary artery pressure of LEVADEX™, dihydroergotamine mesylate (DHE) administered intravenously (IV) and placebo. In the trial, there was no statistically significant difference between the LEVADEX and placebo groups in the primary endpoint of pulmonary artery pressure over two hours after administration. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.
LEVADEX was well tolerated and there were no drug-related serious adverse events reported. There were no clinically significant changes in any cardiovascular parameters measured in this trial. There were no mean increases in QT interval in the LEVADEX group. All pharmacokinetic results in this trial were consistent with those reported in previous LEVADEX trials.
"Intravenous DHE has been used safely for over 60 years, and we wanted to evaluate whether LEVADEX, with its novel administration through the lung, would have an effect on pulmonary artery pressure. We are pleased to report that LEVADEX did not have an effect on pulmonary artery pressure compared to placebo and was, in fact, less than that seen with IV DHE," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals.
Pulmonary artery pressure in the IV DHE group was higher than both the LEVADEX and placebo groups. In addition, even after a second dose of LEVADEX was administered two hours after the first dose, pulmonary artery pressure was not higher in the LEVADEX group than in the IV DHE group.
The PD trial was a randomized, double blind, placebo controlled, three-way, crossover trial in 24 healthy adults and was 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 compared 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 evaluated 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.
MAP Pharmaceuticals, Inc.