FDA OKs New Asthma Treatment for Adults and Adolescents

The FDA has approved Teva’s newest asthma treatment for adolescent and adult patients. AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) is delivered via Teva’s RespiClick breath-activated, multi-dose dry powder inhaler (MDPI) and is indicated for the treatment of asthma in patients 12 years and older.

AirDuo RespiClick, a corticosteroid and long-acting beta2-adrenergic agonist, is a fixed dose combination product with the same active ingredients as Advair. The treatment was approved in 3 strengths: 55/14 mcg, 113/14 mcg, and 232/14 mcg. It is administered as 1 inhalation twice daily.

The FDA’s approval is based on data from a clinical trial in which AirDuo RespiClick’s safety and efficacy were evaluated in adolescent and adult patients. In the study, the treatment showed greater effectiveness in improving lung function compared with a placebo.

The most common adverse effects reported by trial participants include nasopharyngitis, headache, cough, oral candidiasis, and back pain.

The product is expected to be available by prescription in the US market later this year.