Almirall and Forest Labs have announced positive results from the Phase 3 AUGMENT/COPD study of their fixed dose combination aclidinium bromide/formoterol fumarate dry powder inhaler in patients with COPD. The announcement followed several weeks after the companies announced positive results from another Phase 3 study of aclidinium/formoterol, the ACLIFORM/COPD study.
Both combinations tested (400/6mcg and 400/12mcg) showed statistically significant improvement in lung function versus placebo; however, only the 400/12mcg combination showed statistically significant improvement versus formoterol alone for change from morning predose trough FEV1 at 1 hour post dose. Both combinations were well tolerated.
Almirall Chief Scientific Officer Bertil Lindmark commented, “We are very pleased with these results which confirm the efficacy and safety profile of the novel combination of aclidinium/formoterol. The positive results in breathlessness and quality of life measures combined with the patient preferred Pressair/Genuair multidose device could place this new combination as a treatment option for patients suffering from COPD. The successful completion of both pivotal studies marks an important milestone towards achieving an innovative global respiratory franchise around aclidinium and the Almirall’s Genuair inhaler.”
Forest Research Institute President Marco Taglietti said, “By successfully achieving the primary endpoints in these two pivotal trials, we have demonstrated that aclidinium/formoterol, 400/12mcg, delivers statistically significant improvement in lung function. The success of this Phase 3 program supports the potential of aclidinium/formoterol as a new treatment option for COPD patients who could benefit from the enhanced bronchodilation of two complementary, proven therapies.”
The two companies say that they plan to submit regulatory filings to both the FDA and EMA in the fourth quarter of 2013.
Read the Almirall/Forest Labs press release.
