MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

Jul 13 2010

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced results from a clinical trial comparing the pharmacokinetics (PK) and safety of LEVADEX™ orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. The trial was designed to measure whether systemic absorption and exposure in smokers is greater than in non-smokers. In the trial, the systemic absorption of LEVADEX was not higher and systemic exposure to DHE was not greater in smokers than in non-smokers. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.  

The PK trial was a single dose, open-label, crossover trial designed to compare the PK of LEVADEX to intravenous DHE (IV DHE) in both smokers and non-smokers. In the trial, subjects were randomized to receive either a single dose of LEVADEX or IV DHE (DHE 45) and then crossed over to the alternate treatment.  Study drug administration was followed by 48 hours of serial blood sample collections, repeat ECGs, spirometry and vital sign assessments.  The trial included healthy adult volunteers, 23 were smokers and 24 were non-smokers.  LEVADEX was well-tolerated and no drug related serious adverse events were reported.

"We are pleased to have completed our PK trial with these results," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "In addition, we are pleased to report that we have completed enrollment in our pharmacodynamic trial as we continue to make progress with our remaining clinical trials to support an NDA submission for LEVADEX in the first half of 2011."

This PK trial is the first trial completed of the four remaining trials required to support a new drug application (NDA) submission for LEVADEX. The other trials include an ongoing 12 month open-label safety extension of the Phase 3 FREEDOM-301 trial, a pharmacodynamic trial and a thorough QT trial. The Company anticipates that subjects in these trials will complete treatment in 2010.