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Almirall SA and Forest Laboratories Inc Announces Positive Phase III Combo Results from its Second Study for Aclidinium and Formoterol

Thursday, 2 May 2013 02:17am EDT 

Almirall SA and Forest Laboratories Inc announced positive results from AUGMENT/COPD, the second six-month pivotal phase III clinical trial evaluating the efficacy and safety of investigational fixed dose combinations of aclidinium bromide (LAMA) and formoterol fumarate (LABA) for the treatment of Chronic Obstructive Pulmonary Disease (COPD), delivered in the Pressair inhaler. The 400/12mcg combination of aclidinium/formoterol given twice daily demonstrated improvements in change from baseline for the co-primary endpoints of Forced Expiratory Volume (FEV1) at one hour post-dose versus aclidinium 400mcg (p<0.0001), and morning predose trough FEV1 versus formoterol 12mcg at week 24 (p<0.05). The 400/6mcg combination demonstrated improvements in (FEV1) at one hour post-dose versus aclidinium 400mcg (p<0.0001). For the change from baseline in morning pre-dose trough FEV1, the 400/6mcg combination did not reach significance versus formoterol 12mcg at week 24 (p>0.05). The positive results of the aclidinium/formoterol 400/12mcg combination in the study are consistent with the improvement in lung function demonstrated by aclidinium/formoterol 400/12mcg in the previously completed ACLIFORM/COPD Phase III study. In both studies, the 400/12mcg dose successfully met the required regulatory Combination Rule for testing two or more drugs combined in a single dosage form. 

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