The FDA on Monday approved Tudorza™ Pressair™ (aclidinium bromide inhalation powder) for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Forest Laboratories is distributing the drug in the U.S. under a license with Barcelona, Spain-based Almirall; the two companies co-developed the drug.

Tudorza is administered twice-daily using the Pressair multiple-dose dry powder inhaler, which delivers 60 doses of aclidinium bromide powder for inhalation. Tudorza produces bronchodilation by inhibiting acetylcholine’s effect on muscarinic receptors in the airway smooth muscle.

Forest expects Tudorza Pressair to be available to wholesalers in the fourth quarter.

Tudorza Pressair’s clinical development program included a dose-ranging trial and three confirmatory pivotal trials evaluating the efficacy and safety of Tudorza 400 mcg twice daily in 1,276 patients. Enrolled patients had a clinical diagnosis of COPD, were 40 years of age or older, 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 three pivotal trials, Tudorza Pressair demonstrated statistically significant improvements in bronchodilation, as measured by change from baseline in the primary endpoint of morning pre-dose trough FEV1 at 12 weeks compared to placebo. 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.

The most common adverse reactions that occurred in the Tudorza Pressair group with a frequency of greater than or equal to 3% and exceeding placebo were headache (6.6% vs 5.0%), nasopharyngitis (5.5% vs 3.9%), and cough (3.0% vs 2.2%). Three long-term safety studies, evaluating 891 patients treated with Tudorza Pressair 400 mcg twice daily for 40 to 52 weeks, reported similar adverse events.

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