Positive Topline Results for Aclidinium/Formoterol Combo Inhaler for COPD

April 16, 2013

MADRID (Reuters) Apr 16 - Almirall and Forest Laboratories today announced positive topline results from a phase III trial evaluating the efficacy and safety of fixed dose combinations of aclidinium bromide and formoterol fumarate delivered by Almirall's inhaler Genuair (Pressair in the US) for COPD.

Both combinations of aclidinium/formoterol (400/6 mcg and 400/12 mcg twice daily) demonstrated statistically significant improvements in the co-primary endpoints of change from baseline in morning pre-dose FEV1 (vs formoterol 12 mcg) and in FEV1 at one-hour post-dose (vs aclidinium 400 mcg) at 24 weeks, the company said.

In addition, both combinations of aclidinium/formoterol provided statistically significant improvements versus placebo in these two variables.

"By successfully achieving the primary endpoints in this pivotal trial, we have demonstrated the superior improvement in lung function that can be achieved by combining two proven bronchodilators with complementary modes of action," Dr. Marco Taglietti, President of Forest Research Institute, said in a statement.

"We expect this novel combination of aclidinium/formoterol to offer patients a new option in COPD treatment. In addition to the improved efficacy shown in this study, the safety profile was comparable to placebo," Bertil Lindmark, Almirall's Chief Scientific Officer, added.

Results of a second phase III trial for the inhaler are expected in the coming weeks.

If the next round of results is also positive, the companies will file new drug applications to medical authorities in the United States and Europe, Almirall said.