MAP0005 comparable FEV1 to Symbicort

The USA's MAP Pharmaceuticals has reported positive results from a Phase IIa clinical study evaluating MAP0005 for the potential treatment of asthma and chronic obstructive pulmonary disease. The product is a single-particle combination of the corticosteroid budesonide and formoterol, a long-acting beta-2-agonist, delivered to the respiratory tract using the company's proprietary Tempo inhaler.

The randomized, open-label, active-controlled, crossover, safety and dose response study compared two different emitted doses of MAP0005, 104/5.4mcg and 312/16.2mcg of budesonide/formoterol with the 160/9mcg dose of the leading commercially-marketed combination product of the same two agents, Anglo-Swedish drug major AstraZeneca's Symbicort (budesonide and formoterol), which earned $1.58 billion in full-year 2007. Maximum change in forced expiratory volume in one second (FEV1) was similar for all three treatments, as was time to maximum change in FEV1. Plasma levels of budesonide were dose proportional for MAP0005. No serious or unexpected adverse events were reported in the study, and MAP0005 was well tolerated, the firm noted, adding that the Tempo inhaler delivered budesonide more consistently than the commercially-available product across the study population.