Thursday, Forest Laboratories, Inc. (FRX) and Almirall, S.A. (ALM.MC) announced positive results from Accord COPD I, the first of three pivotal Phase III study comparing two different doses of aclidinium BID versus placebo. The results are consistent with 15 day phase II study comparing with tiotropium and placebo. Aclidinium bromide is a long-acting inhaled anticholinergic bronchodilator under development for the treatment of Chronic Obstructive Pulmonary Disease, or COPD.
COPD is a disorder where airways in the lungs typically lose their elasticity, produce excess mucus and become thick and inflamed, limiting the passage of air. According to the World Health Organisation COPD is a global epidemic, with an estimated 210 million people are affected worldwide.
The results from twelve week randomized, double-blind, placebo controlled trial, enrolling 561 patients in North America, to evaluated efficacy and safety of aclidinium bromide 200µg or 400µg or placebo, met its primary endpoint. Aclidinium bromide was administered twice daily by inhalation, in patients with moderate to severe COPD.
The primary endpoints included, FEV measuring forced expiratory volume in one second, or the amount of air that can be exhaled in the first second, following an inhalation. Morning trough FEV is the average of two FEV measurements within 1 hour before morning treatment administration.
Aclidinium was well tolerated in this study. It demonstrated statistically significant changes from baseline values in morning trough FEV compared to placebo, at 86mL and 124 mL for the 200µg and 400µg BID groups, respectively. The study's Mean baseline FEV at randomization ranged from 1,332mL to 1,376mL. It was also consistent with findings from a Phase II study, comparing aclidinium vs tiotropium and placebo.
Most frequent adverse event observed among patients receiving aclidinium 200µg, aclidinium 400µg and placebo, was COPD exacerbation, which occurred in 9.2%, 7.4% and 12.4% of patients, respectively. Other adverse events included dyspnea, headache and nasopharyngitis and occurred at similar rates across the treatment groups.
Results from two additional placebo-controlled Phase III studies namely, Accord COPD II and Attain, assessing efficacy and safety of aclidinium bromide in patients with COPD are currently underway, one in North America and the other in Europe and the rest of the world. The study results are expected between the second half of 2010 and early 2011.
Forest Labs 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.
"We are very pleased with the results of this study which confirm the decision made by Forest and Almirall to investigate a BID dosing regimen for aclidinium. Together, these data suggest that aclidinium administered BID provides a clinically important bronchodilatory effect with good tolerability in patients with COPD," said Lawrence Olanoff, president and chief operating officer of Forest Laboratories.
FRX closed Wednesday's trading at $31.91, on the NYSE.
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