FDA approves Tudorza Pressair for long-term COPD maintenance
FDA approves Tudorza Pressair for long-term COPD maintenance
The FDA has approved Tudorza Pressair (aclidinium bromide inhalation powder; Forest Laboratories and Almirall) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
The therapy received approval after results from a dose-ranging trial and three confirmatory pivotal trials showed it was safe and effective. The two 12-week and one 24-week pivotal placebo-controlled trials evaluated the efficacy and safety of aclidinium bromide inhalation powder 400 mcg 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 of less than 0.7.
In all three pivotal trials, aclidinium bromide inhalation powder 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 with placebo.
The mean 12-week pre-dose FEV1 improvements vs. placebo were 0.12 L, 0.07 L, and 0.11 L in the 3 trials, with a 24-week improvement of 0.13 L in the 6-month trial. Mean peak improvements in lung function (FEV1) assessed after the first dose of aclidinium bromide were similar to those observed at week 12 in each study.
Aclidinium bromide 400 mcg 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.
Aclidinium bromide is administered using a multiple-dose dry powder inhaler, Pressair, capable of delivering 60 doses. 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. The treatment is not indicated for rescue therapy in acute episodes of bronchospasm.
For more information call (800) 678-1605 or visit www.FRX.com or www.almirall.com.
