Forest Laboratories and Almirall have reported positive results from the ACLIdinium/FORMoterol fumarate combination for Investigative use in the treatment of moderate to severe COPD (ACLIFORM/COPD) Phase III study.
ACLIFORM/COPD is the second pivotal trial designed to assess the safety and efficacy of aclidinium bromide (LAMA) and formoterol fumarate (LABA) fixed dose combinations, delivered in the Pressair inhaler.
Forest Research Institute president Dr. Marco Taglietti said, "The success of this phase III 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," Taglietti added.
Statistically significant improvements in change from baseline for the co-primary endpoints of Forced Expiratory Volume (FEV1) at one hour after dose was demonstrated by 400/12mcg combination of aclidinium/formoterol compared to 400mcg aclidinium and morning predose trough FEV1 against formoterol 12mcg at week 24.
The study also reported statistically significant improvements by 400/6mcg combination in (FEV1) at one hour post-dose against aclidinium 400mcg.
The 400/6mcg combination failed to reach significance compared to formoterol 12mcg at week 24, for the change from baseline in morning pre-dose trough FEV1.
Both the combinations achieved statistically significant improvements compared to placebo in the above two comparisons.
Almirall chief scientific officer Dr. Bertil Lindmark said, "The successful completion of both pivotal studies mark an important milestone towards achieving an innovative global respiratory franchise around aclidinium and the Genuair inhaler."
Constant positive results demonstrated by the aclidinium/formoterol 400/12mcg combination in the study to statistically significant improvement in lung function demonstrated by aclidinium/formoterol 400/12mcg in the previous ACLIFORM/COPD Phase III study were noted.
The 400/12mcg dose met the required regulatory combination rule for testing two or more drugs combined in a single dosage form in both studies.
Both aclidinium/formoterol treatment arms were well-tolerated in the study in which most common adverse events include cough, nasopharyngitis, headache, urinary tract infection, headache, urinary tract infection and so on.
