Interim safety review of LEVADEX completed by MAP Pharmaceuticals

Oct 29 2009

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that it has completed a planned interim safety review of the open-label, long-term safety extension of the company's Phase 3 FREEDOM 301 clinical trial with its LEVADEX(TM) orally inhaled migraine therapy.

To date, more than 400 patients have completed at least six months of treatment and over 7,800 headaches have been treated in the safety extension. No drug-related serious adverse events have been reported.

The goal of the ongoing open-label, long-term safety extension is to evaluate overall safety, including pulmonary and cardiovascular safety, of LEVADEX in 300 patients for six months and 150 patients, including asthmatics, for 12 months as part of a potential New Drug Application. The trial is being conducted under a Special Protocol Assessment with the United States Food and Drug Administration.

The interim review of the data was conducted after a pre-specified number of patients had completed six months of exposure to LEVADEX and was also reviewed by an independent Data Monitoring Committee (DMC). The DMC is an independent group of clinical trial experts, including physicians, formed to critically review and evaluate patient safety data generated in the FREEDOM 301 trial with the objective of ensuring clinical trial patient safety, quality of the data collected and continued scientific validity of the trial design. On an ongoing basis, the DMC reviews data from the safety extension, including results of both pulmonary lung function evaluations using standard measures such as DLco and FEV1 and cardiac evaluations using EKGs, echocardiograms and chest X-rays.