The filing of the NDA was supported by the results of a placebo-controlled, double-blind Phase III trial in which patients were given aclidinium bromide 400 mcg or 200 mcg twice daily or placebo.
The results of the trial showed improvement in morning FEV1 versus placebo at week 12.
In the trial, aclidinium 400mcg twice-a-day was generally well tolerated.
Forest Labs has licensed US rights for aclidinium from Almirall, while Almirall maintains rights for the rest of the world.