MAP Pharmaceuticals confirmed with the FDA that four clinical trials, which already were included in the company’s operating budget, are required to support a new drug application (NDA) submission for Levadex. Patients in all of these trials are expected to complete treatment in 2010.
MAP Pharmaceuticals claimed that Open-label safety trial is a 12 month open-label trial, evaluating overall safety, including pulmonary and cardiovascular safety, of Levadex in at least 300 patients for six months and 150 patients for 12 months, including asthmatics.
Additionally, Pharmacokinetics (PK) trial is a single dose, open-label, crossover trial, designed to compare the PK of Levadex to intravenous dihydroergotamine mesylate (IV DHE) in both smokers and non-smokers.
MAP Pharmaceuticals said that Pharmacodynamics (PD) trial, randomised, double blind, placebo controlled, three way, crossover trial in approximately 24 healthy adults, 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.
Reportedly, QT trial is expected to evaluate whether Levadex has an effect on QT interval as measured by electrocardiogram.
MAP Pharmaceuticals claimed that with respect to chemistry, manufacturing and controls (CMC) requirements, it has also received feedback on the content required for NDA submission. Registration batch manufacturing is complete and the batches are on stability. The company is progressing toward readiness for pre-approval inspections with its commercial manufacturing partners.
Timothy Nelson, president and CEO of MAP Pharmaceuticals, said: “We continue to make good progress with our Levadex program. Recent clinical and CMC discussions with the FDA have provided us with clarity regarding the content to be included in our NDA submission.
“We plan to submit an NDA for Levadex for the acute treatment of migraine in the first half of 2011, bringing us one step closer to our goal of providing the underserved migraine patient population with a new and differentiated treatment option.”