Forest and Almirall see early filing of COPD drug aclidinium with US FDA; Appointment at Almirall

Spain’s largest pharma company Almirall (ALM. MC) and US marketing partner Forest Laboratories (NYSE: FRX) revealed on Friday that they have recently submitted a New Drug Application to the US Food and Drug Administration for aclidinium bromide, a long-acting inhaled antimuscarinic agent developed for the treatment of COPD, which is a great deal sooner than the early-2012 filing they had previously expected.

The submission includes efficacy data from a large Phase III double-blind placebo-controlled program in which patients received aclidinium bromide 400mcg or 200mcg twice daily or placebo. In the pivotal studies, aclidinium 400mcg twice-a-day, the proposed to-be-marketed dose, produced significant improvement in morning trough FEV1 versus placebo at week 12 (p<0.0001), the primary endpoint assessed as support for the US NDA, and at week 24 (p<0.0001), which was the primary endpoint assessed in one study as support for a European filing.

Additionally, safety data collected from the Phase III program demonstrated that aclidinium 400mcg twice-a-day was generally well tolerated, with an incidence of adverse events that was low and similar across the study treatment arms. The most commonly reported adverse reactions were headache and nasopharyngitis.