MAP Pharmaceuticals initiates LEVADEX-intravenous DHE comparative trial

Feb 16 2010

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that the Company initiated a trial to compare the pharmacokinetics (PK), safety and metabolic profiles of LEVADEX™ orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.

This PK trial is one of two remaining trials to be initiated in support of a New Drug Application (NDA) submission for LEVADEX as previously requested by the U.S. Food and Drug Administration (FDA). In addition to the PK trial, the Company is conducting an ongoing 12 month open-label safety extension of its Phase 3 FREEDOM-301 trial, which has completed enrollment, and also plans to conduct a pharmacodynamic trial. The Company anticipates that patients in these trials will complete treatment in 2010.

"Earlier this year, we announced that a second pivotal efficacy trial is not required for our NDA submission," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "The initiation of this PK trial is an important step for the Company as we continue to focus on completing our remaining clinical trials to support our NDA submission for LEVADEX."

This PK trial is a single dose, open-label, crossover trial designed to compare the PK of LEVADEX to intravenous DHE in both smokers and non-smokers. The trial includes healthy adult volunteers, 24 of whom are smokers and 24 of whom are non-smokers.