MAP Pharmaceuticals (MAP) has completed a planned interim safety review of the open-label, long-term safety extension of its phase 3 FREEDOM 301 clinical trial, with its Levadex orally inhaled migraine therapy.
Reportedly, 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.
The company said that 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 FDA.
The company has added that 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).