An orally-inhaled migraine therapy known as LEVADEX has entered into a pharmacodynamics (PD) trial. The acute effect of LEVADEX, produced by MAP Pharmaceuticals, Inc, will be compared to intravenous dihydroergotamine mesylate (IV DHE) and placebo on pulmonary artery pressure.
An orally-inhaled migraine therapy known as LEVADEX™ has entered into a pharmacodynamics (PD) trial. The acute effect of LEVADEX™, produced by MAP Pharmaceuticals, Inc, will be compared to intravenous dihydroergotamine mesylate (IV DHE) and placebo on pulmonary artery pressure.
"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, in a press release. "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.”
The drug is a formulation of dihydroergotamine mesylate and has already completed phase 3 efficacy development. It is administered by the patients themselves by using the pharmaceutical company’s TEMPO® inhaler. During phase 3 testing, it was shown to have met all four co-primary endpoints at the two hour mark. It effectively produced pain relief, and patients were left free of phonophobia, photophobia, and nausea. It was well tolerated and lacked serious adverse events.
The double blind trial will involve 24 healthy adults and will be randomized, and placebo controlled. The acute effects of LEVADEX™, IV DHE, and placebo, will be compared by examining regular echocardiogram measurements on the participants over a two hour period. The pharmacokinetics of LEVADEX™, and IV DHE and its metabolites will also be compared as well as the effects of the routes of delivery on cardiac function.