After quite a few years of trying, Forest Laboratories and Almirall have submitted a New Drug Application to regulators in the USA for aclidinium bromide, their treatment for chronic obstructive pulmonary disease.
The filing for the drug, a long-acting inhaled antimuscarinic agent, includes efficacy data from a large Phase III programme in which patients received aclidinium 400 mcg or 200 mcg twice daily or placebo. In the studies, aclidinium 400 mcg twice-a-day, the proposed to-be-marketed dose, produced significant improvement in morning trough FEV1 versus placebo at week 12 and at week 24.
The data collected from the Phase III programme demonstrated that the higher dose was generally well tolerated, and the most commonly reported adverse reactions were headache and nasopharyngitis.
The road to filing has been a difficult one with a European submission for a once-daily dosing being pulled last January. In 2009, Almirall was asked by the US Food and Drug Administration to look at higher and more frequent dosing of the drug in additional studies.