Almirall and Forest Laboratories have announced that a phase III trial that compared the chronic obstructive pulmonary disease (COPD) therapy aclidinium bromide BID with a placebo has yielded positive results.
In a statement, the companies explained that the study met its primary endpoint of having aclidinium bromide producing statistically significant changes from baseline in the morning pre-dose trough FEV versus the placebo after three months.
Commenting on the news, Per-Olof Andersson, executive director of research and development at Almirall, said that the firm is "encouraged" by the fruitful top-line results.
The results are consistent with earlier research which compared aclidinium with tiotropium and a placebo.
Lawrence Olanoff, president and chief operating officer of Forest Laboratories, added: "These data suggest that aclidinium administered BID provides a clinically-important bronchodilatory effect with good tolerability in patients with COPD."
This news follows Alimirall's recent announcement that the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for its silodosin drug.