MOUNTAIN VIEW, Calif., Sept. 8 /PRNewswire-FirstCall/ — 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 e
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