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Positive Phase III Results With Aclidinium/Formoterol in COPD

Regulatory filing planned for fourth quarter 2013 (May 1)

Positive results have been reported from the AUGMENT/COPD trial, the second 6-month pivotal phase III study of investigational fixed-dose combinations of aclidinium bromide (LAMA) and formoterol fumarate (LABA) (Forest Laboratories/Almirall, S.A.), delivered in the Pressair inhaler.

The combination of aclidinium 400 mcg/formoterol 12 mcg demonstrated statistically significant improvements in the change from baseline for the co-primary endpoints of forced expiratory volume in 1 second (FEV1) at 1 hour post-dose versus aclidinium 400 mcg (P < 0.0001) and morning predose trough FEV1 versus formoterol 12 mcg at week 24 (P < 0.05). The 400 mcg/6 mcg combination demonstrated statistically significant improvements in FEV1 at 1 hour post-dose versus aclidinium 400 mcg (P < 0.0001). For the change from baseline in morning pre-dose trough FEV1, the 400 mcg/6 mcg combination did not reach statistical significance versus formoterol 12 mcg at week 24.

The positive results of the aclidinium/formoterol 400 mcg/12 mcg combination in this study were consistent with the statistically significant improvement in lung function demonstrated by aclidinium/formoterol 400 mcg/12 mcg in the previously completed ACLIFORM/COPD phase III trial.

Both studies included secondary endpoints. The endpoints analyzed to date are the change from baseline versus placebo at 24 weeks in the Transitional Dyspnea Index (TDI), which measures breathlessness, and in the St. George’s Respiratory Questionnaire (SGRQ), a respiratory-specific disease-related quality-of-life assessment. The two combinations achieved a meaningful clinically important difference (MCID) of a one-point change (P < 0.0001) in the TDI in both studies, and a four-point change (P < 0.0001) in the SGRQ in the AUGMENT/COPD study.

The AUGMENT/COPD and ACLIFORM/COPD trials enrolled 1,692 and 1,729 patients with moderate-to-severe COPD, respectively.

Regulatory filing in the U.S. is planned for the fourth quarter of 2013.

Source: Forest Laboratories; May 1, 2013.

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