Forest Laboratories and Almirall announced that the FDA has approved Tudorza Pressair (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
The Tudorza Pressair clinical development program included a dose-ranging trial and 3 confirmatory pivotal trials. The two 12-week and one 24-week pivotal placebo-controlled trials evaluated the efficacy and safety of Tudorza 400mcg twice daily in 1,276 patients. Patients enrolled in these trials had a clinical diagnosis of COPD, were ≥40 years of age, had a smoking history of at least 10 pack-years, a forced expiratory volume in one second (FEV1) of at least 30% and less than 80% of predicted normal value, and a ratio of FEV1 over forced vital capacity (FEV1/FVC) of less than 0.7.
In all 3 pivotal trials, Tudorza Pressair demonstrated statistically significant improvements in bronchodilation, as measured by change from baseline in morning pre-dose trough FEV1 at 12 weeks (the primary endpoint) compared to placebo. The mean 12-week pre-dose FEV1 improvements vs. placebo were 0.12L, 0.07L, and 0.11L in the 3 trials, with a 24-week improvement of 0.13L in the 6-month trial. Mean peak improvements in lung function (FEV1) assessed after the first dose of Tudorza were similar to those observed at Week 12 in each study.
Tudorza Pressair 400mcg is a twice-daily inhaled long-acting anticholinergic, also referred to as a long-acting muscarinic antagonist (LAMA). When given by inhalation, aclidinium produces bronchodilation by inhibiting acetylcholine’s effect on the muscarinic M3 receptor in the airway smooth muscle.
Tudorza is administered using a multiple-dose dry powder inhaler, Pressair, which delivers 60 doses of aclidinium bromide powder for inhalation. The Pressair inhaler has a colored control window and audible “click” which confirm successful inhalation of the dose and a dose indicator to let patients know how many doses remain in the inhaler.
Tudorza Pressair is expected to be available in the fourth quarter of 2012.