Two New Breath-Activated Inhalers Gain FDA Approval for Asthma
Teva announced that the Food and Drug Administration (FDA) has approved two new breath-activated, multi-dose dry powder inhalers for asthma; AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) and ArmonAir RespiClick (fluticasone propionate inhalation powder).
AirDuo RespiClick combines a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) and is indicated for the treatment of asthma in patients aged ≥12 years. ArmonAir RespiClick is an inhaled corticosteroid indicated as maintenance treatment of asthma as prophylactic therapy in patients aged ≥12 years.
The FDA approval was based on data from Teva's clinical development program, which includes Phase 3 trials on the efficacy and safety of treatments in adolescents and adults with asthma. In the two double-blind studies, both AirDuo and ArmonAir showed a clinically relevant and greater benefit vs. placebo in the improvement of lung function after 12 weeks of treatment as measured by forced expiratory volume in one second (FEV1).
Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Corticosteroids have been shown to have a wide range of actions on multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (eg, histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation. In vitro tests show that salmeterol is a potent and long-lasting inhibitor of the release of mast cell mediators, such as histamine, leukotrienes, and prostaglandin D2, from human lung.
AirDuo RespiClick will be available in 55/14mcg, 113/14mcg, and 232/14mcg strengths. ArmonAir RespiClick will be available in 55mcg, 113mcg, and 232mcg strengths. Both RespiClick inhalers are expected to launch later this year.
“Prescribing the lowest effective dose of a medication is a key clinical objective in the treatment of asthma. It's equally important that patients use their asthma inhalers correctly to ensure medicine is reaching the lungs,” said Dr. Lyndon Mansfield, MD, Clinical Professor of Pediatrics, Paul Foster School of Medicine, El Paso, TX. “With research indicating that a significant number of patients still do not properly use their metered-dose inhalers, I am pleased that more asthma treatments and strengths are now approved in a device that eliminates the need for hand-breath coordination during inhalation.”
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