MAP Pharmaceuticals has submitted a new drug application (NDA) to the US FDA for its Levadex inhaled dihydroergotamine (DHE) for the treatment of migraines. The delivery device used for the product is the company’s proprietary breath-activated MDI, the Tempo inhaler.
MAP recently published data from its Phase 3 FREEDOM-301 trial, in which Levadex met all 4 primary endpoints, with statistically significant improvement in pain relief, nausea, and light and sound sensitivities. Compared to placebo, Levadex caused no significant changes in lung function and only small differences in incidences of nausea and medication aftertaste.
“This NDA submission marks a major corporate milestone for MAP Pharmaceuticals and brings us one step closer to our goal of providing the underserved migraine patient population with a potential new treatment option,” commented Timothy Nelson, President and CEO of MAP. “Our comprehensive development program evaluated LEVADEX in approximately 1,000 patients for up to one year, treating nearly 10,000 migraines. If approved by the FDA, LEVADEX could potentially provide a new treatment option for migraine sufferers, including the millions of patients whose migraines are not well treated today.”
Read the MAP press release.
