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News Breaks
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October 29, 2009
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| 07:30 EDT |  | MAPP |
| theflyonthewall.com: | Map Pharmaceuticals completes interim safety review of Levadex | | MAP Pharmaceuticals 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 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. :theflyonthewall.com |
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