FDA Approves 2 New Options for Asthma Treatment
The FDA has approved AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) and ArmonAir RespiClick (fluticasone propionate inhalation powder) for the treatment of adolescent and adult patients with asthma.
AirDuo is a combination of corticosteroid and long-acting beta2-adrenergic agonist indicated for treatment of patients with asthma aged 12 years or older. ArmonAir, an inhaled corticosteroid, is indicated for maintenance treatment of asthma in patients 12 years and older.
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Both have been approved in 3 strengths: 55/14 mcg, 113/14 mcg, and 232/14 mcg administered twice daily for AirDuo, and 55 mcg, 113 mcg, and 232 mcg administered twice daily for ArmonAir.
The approval of both products was based upon the results of 3 Phase III trials evaluating the efficacy and safety of the treatments. In 2 double-blind studies, both therapies were associated with clinically relevant improvement of lung function after 12 weeks of treatment compared with placebo, as measured by FEV1.
The most common adverse events associated with use of AirDuo were nasopharyngitis, headache, cough, oral candidiasis, and back pain. The most common adverse events associated with use of ArmonAir were nasopharyngitis, headache, cough, oral candidiasis, and upper respiratory tract infection.
—Michael Potts
Reference:
Teva. Teva announces FDA approval of two new Respiclick® maintenance inhalers for the treatment of asthma [press release]. January 30, 2017. http://www.businesswire.com/news/home/20170130005298/en/.