Levadex is an orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine. The trial was initiated in support of a planned new drug application (NDA) submission for Levadex to the 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.
MAP Pharmaceuticals said that the PD trial is a randomised, 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.
Furthermore, the trial is also expected to 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 1.0mg IV DHE.
Timothy Nelson, president and CEO of MAP Pharmaceuticals, said: “We continue to progress our clinical trials for our NDA submission for Levadex. 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 US, including those who are not helped by currently available migraine therapies.”