FDA Approved Drugs » 2012
Medical Areas: Immunology | Pulmonary/Respiratory Diseases | Family Medicine | Infections and Infectious Diseases
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Forest Laboratories
Approval Status: Approved July 2012
Treatment Area: maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease
Tudorza Pressair (aclidinium bromide inhalation powder) consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide is an anticholinergic with specificity for muscarinic receptors.
Tudorza Pressair is specifically indicated for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Tudorza Pressair is a breath-actuated multi-dose dry powder inhaler metering 400 mcg of aclidinium bromide per actuation. The recommended dose of Tudorza Pressair is one oral inhalation of 400 mcg, twice daily.
FDA ApprovalThe FDA approval of Tudorza Pressair was based on a dose-ranging trial (Trial A) for nominal dose selection and three confirmatory trials (Trials B, C, and D). Dose-ranging trial (Trial A)This randomized, double-blind, placebo-controlled, active-controlled, cross-over trial included 7-day treatment periods separated by 5-day washout periods. The trial enrolled 79 subjects who had a clinical diagnosis of COPD, were 40 years of age or older, had a history of smoking at least 10 pack-years, had 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. The subjects received Tudorza Pressair doses of 400 mcg, 200 mcg and 100 mcg twice daily, formoterol active control, and placebo. The effect on trough FEV1 and serial FEV1 in subjects treated with the Tudorza Pressair 100 mcg and 200 mcg twice daily doses was lower compared to subjects treated with the Tudorza Pressair 400 mcg twice daily dose.Confirmatory trials (Trials B, C and D)These randomized, double-blind, placebo-controlled trials enrolled 1,276 subjects who had a clinical diagnosis of COPD, were 40 years of age or older, had a history of smoking at least 10 pack-years, had an FEV1 of at least 30% and less than 80% of predicted normal value, and a ratio of FEV1/FVC of less than 0.7. The subjects received Tudorza Pressair 400 mcg twice daily (n=636) and placebo (n=640). Trials B and C were 3 months in duration, and Trial D was 6 months in duration. Tudorza Pressair 400 mcg resulted in statistically significantly greater bronchodilation as measured by change from baseline in morning pre-dose FEV1 at 12 weeks (the primary efficacy endpoint) compared to placebo in all three trials.
Adverse events associated with the use of Tudorza Pressair may include, but are not limited to, the following:
Tudorza Pressair (aclidinium bromide inhalation powder) consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide is an anticholinergic with specificity for muscarinic receptors. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation.
Singh D, Magnussen H, Kirsten A, Mindt S, Caracta C, Seoane B, Jarreta D, Garcia Gil E A randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients. Pulmonary Pharmacology & Therapeutics 2012 Jun;25(3):248-53
Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, Segarra R, Caracta C, Garcia Gil E Efficacy and safety of twice-daily aclidinium bromide in COPD patients: The ATTAIN study. The European Respiratory Journal : Official Journal of the European Society for Clinical Respiratory Physiology. 2012 Mar 22
Seter K, Dilzer S, Jansat JM, Garcia Gil E, Caracta CF, Ortiz S Safety and pharmacokinetics of multiple doses of aclidinium bromide administered twice daily in healthy volunteers. Pulmonary Pharmacology & Therapeutics 2012 Apr;25(2):193-9
Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF; ACCORD I study investigators Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD 2012 Apr;9(2):90-101
For additional information regarding Tudorza Pressair for bronchospasm associated with chronic obstructive pulmonary disease, please visit the tudorzahcp web page.