Arcapta Neohaler is indicated for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Arcapta 75 mcg was studied in two key Phase III trials lasting 12 weeks in a total of 641 COPD patients.
The drug significantly improved lung function at 24 hours compared to placebo.
It also significantly reduced the need for patients to use daily rescue medication.
Additionally, Arcapta improved health-related quality of life compared to placebo, as measured with the St George’s Respiratory Questionnaire.
The clinical trial program supporting US submission evaluated safety in 2,516 patients who received Arcapta for at least 12 weeks at doses of 75 mcg or more, with results supporting the safety and tolerability profile of Arcapta.
The Arcapta US launch is planned for the first quarter of 2012.