Almirall and Forest report preliminary topline results from the ACCORD COPD II Phase III study of aclidinium bromide in Chronic Obstructive Pulmonary Disease (COPD)

Barcelona and New York, October 29, 2010.- Almirall, S.A. (ALM.MC) and Forest Laboratories, Inc. (NYSE: FRX) today announced top-line results from ACCORD COPD II, a 12-week Phase III study comparing the efficacy and safety of inhaled aclidinium bromide, an investigative bronchodilator, to placebo in 544 patients with moderate to severe COPD. This is the second of three double-blind placebo-controlled pivotal Phase III studies investigating twice-daily (BID) aclidinium bromide 200ug and 400ug. The improvement from baseline in FEV1, the primary endpoint, was statistically significant in the 200ug (p=0.019) and 400ug (p=0.001) BID dose groups, however, for the expected therapeutic dose, 400ug, the magnitude of effect compared to placebo, 72 mL, was less than that observed in three other studies; i) the similarly designed ACCORD COPD I Phase III trial reported in January this year, ii) a previously reported 15-day Phase II trial comparing aclidinium 400ug BID to placebo or tiotropium 18ug once daily, and iii) a recently completed 7-day Phase II trial comparing aclidinium 400ug BID to placebo or formoterol. Across these other trials the difference in FEV1 from baseline ranged from 124 mL to 186 mL.

The release as fetched from its publisher. almirall.com ↗