The trial is a post-marketing requirement (PMR) that was requested by the US Food and Drug Administration (FDA) to evaluate MACE for up to three years with aclidinium bromide
is also the LAMA in Duaklir (aclidinium bromide
/formoterol fumarate), which is marketed in more than 30 countries and under development for the US and China.
Efficacy and safety of twice-daily aclidinium bromide
in COPD patients: the ATTAIN study.
This edition has new drugs, including aclidinium bromide
, felbamate, icosapent ethyl, linaclotide, peginesatide acetate, perampanel, rotigotine, and teriflunomide, and updated group monographs for antipsychotic agents, benzodiazepenes, calcium channel blocking agents, estrogens, macrolides, opioid analgesics, proton pump inhibitors, selective serotonin reuptake inhibitors, and serotonin 5-HT1 receptor agonists.
(Tudorza Pressair; bronchodilator) is a respiratory agent used in chronic obstructive pulmonary disease, chronic bronchitis, and emphysema.
, a long-acting anticholinergic bronchodilator, has been approved as a treatment for chronic obstructive pulmonary disease, for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema, the FDA announced last month.
The majority of a Food and Drug Administration advisory panel recommended that aclidinium bromide
, an inhaled long-acting anticholinergic bronchodilator, should be approved as a treatment for chronic obstructive pulmonary disease, with a postmarketing study that evaluates the cardiovascular safety of the drug.
The company said the once-daily aclidinium bromide
achieved its primary endpoint, showing a statistically significant difference versus placebo in a measure of lung function that is affected in patients with moderate to severe COPD.
Tudorza is administered using a multiple-dose dry powder inhaler, Pressair, which delivers 60 doses of aclidinium bromide
powder for inhalation.
The drug indicated a statistically-significant improvement in lung function in patients with moderate to very severe stable chronic obstructive pulmonary disease when compared with individual component that included either aclidinium bromide
Almirall has announced positive top-line results, which shows that Duaklir (aclidinium bromide
/formoterol 400g/12g twice-daily) met the primary endpoints in the AMPLIFY high-level read-out, demonstrating a statistically significant and clinically relevant improvement in lung function in moderate to very severe stable chronic obstructive pulmonary disease (COPD) patients compared to each individual component (either aclidinium bromide
AstraZeneca today announced positive top-line results from the Phase III AMPLIFY trial for Duaklir (aclidinium bromide
/formoterol 400g/12g twice-daily), which met its primary endpoints, demonstrating a statistically-significant improvement in lung function in patients with moderate to very severe stable chronic obstructive pulmonary disease (COPD) compared to each individual component (either aclidinium bromide