Neurodoc's Blog : MAPP

MOUNTAIN VIEW, Calif., Dec. 21, 2010 /PRNewswire via COMTEX/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced completion of the LEVADEX(TM) open-label safety trial. The Company has now completed the final trial necessary to support a New Drug Application (NDA) for LEVADEX and plans to submit an NDA in the first half of 2011. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 clinical development for the acute treatment of migraine.

"We are pleased to have completed the LEVADEX clinical program. This clinical trial completes a comprehensive 505(b)(2) clinical development program which evaluated the efficacy, safety, pharmacokinetics and pharmacodynamics of LEVADEX in approximately 1,000 patients," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "In 2010, we announced that a second Phase 3 trial would not be necessary for our NDA submission, completed and announced successful results from a pharmacokinetics trial in smokers, a pharmacodynamics trial evaluating pulmonary artery pressure and a thorough QT trial, and we have now completed our open-label safety trial."


The 12 month open-label, safety extension of the Phase 3 FREEDOM-301 trial was designed to evaluate overall safety of LEVADEX over six and 12 months of exposure. In total, more than 475 patients completed six months treatment and more than 250 patients completed 12 months treatment. In this trial no drug-related serious adverse events were reported.

The Company anticipates presenting safety results from the trial at an upcoming scientific conference.

My comment: how s-l-o-w can it go toward what appears to be inevitable FDA approval??