Forest Laboratories, Inc. and Almirall, S A announced they have recently submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for aclidinium bromide, a long-acting inhaled anti-muscarinic agent developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD).

The submission includes efficacy data from a large phase III double-blind placebo-controlled programme 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 programme 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.

Aclidinium bromide is a novel, long-acting inhaled anitmuscarinic agent, which is often referred to as an anticholinergic, that has a long residence time at M3 receptors and a shorter residence time at M2 receptors. When given by inhalation, aclidinium leads to bronchodilation by inhibiting airway smooth muscle contraction. Aclidinium is rapidly hydrolyzed in human plasma to two major inactive metabolites. Forest Laboratories, Inc. licensed US rights for aclidinium from Almirall, while Almirall maintains rights for the rest of the world. The companies are jointly involved in the development of the compound.

Aclidinium bromide was administered to patients in the trials using a novel, investigational, state-of-the-art Multidose Dry Powder Inhaler (MDPI). This inhaler was designed with a feedback system which, through a 'colored control window' and an audible click, helps confirm that the patient has inhaled correctly. It contains multiple doses of aclidinium, includes a visible dose-level indicator and also incorporates safety features such as an anti-double-dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.

The World Health Organization (WHO) has described COPD as a global epidemic; an estimated 64 million people have COPD worldwide. In patients with COPD the airways in the lungs typically lose their elasticity, produce excess mucus and become thick and inflamed, limiting the passage of air. The most common symptoms of COPD are breathlessness (or a "need for air"), abnormal sputum (a mix of saliva and mucus in the airway), and a chronic cough. Daily activities, such as walking up a short flight of stairs or carrying a suitcase, can become very difficult as the condition gradually worsens. There are significant unmet needs in the treatment of COPD and new therapies may be of value.

Almirall is an international pharmaceutical company based on innovation and committed to health. It focuses its research resources on therapeutic areas related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), gastrointestinal disorders, psoriasis and other dermatological conditions.

Forest Laboratories' longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective and respiratory medicine.