Almirall, Forest Labs submit aclidinium bromide NDA to FDA for treatment of COPD

Jun 30 2011

Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A. (ALM.MC) announced they have recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for aclidinium bromide, a long-acting inhaled antimuscarinic agent developed for the treatment of COPD.

The submission includes efficacy data from a large Phase III double-blind placebo-controlled program in which patients received aclidinium bromide 400 mcg or 200 mcg twice daily or placebo. In the pivotal 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 (p<0.0001), the primary endpoint assessed as support for the U.S. 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 400 mcg 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.

Source: Forest Laboratories