FDA Approves Two New Breath-Activated Inhalers for Asthma

The US Food and Drug Administration (FDA) granted approval for two breath-activated, multi-dose dry powder inhalers to treat asthma: fluticasone propionate (AirDuo RespiClick/Teva) and fluticasone propionate inhalation powder (ArmonAir RespiClick/Teva).

The approval is based on data from a clinical development program that included phase 3 trial results (two double-blind studies) to test the efficacy and safety of treatments in teens and adults with asthma.

Researchers reported that AirDuo RespiClick combines a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) and is indicated for treating asthma in patients older than 12 years. ArmonAir RespiClick is an inhaled corticosteroid specifically indicated as prophylactic therapy in asthma patients older than 12 years.

The studies showed that according to a measurement of forced expiratory volume in one second (FEV1), both AirDuo and ArmonAir significantly improved lung function after 12 weeks of treatment. The two inhalers were found to be more clinically relevant and beneficial than the placebo.

Researchers have generally agreed that prescribing the lowest effective dose of a medicine is integral to asthma treatment. As Lyndon Mansfield, MD, Clinical Professor of Pediatrics, Paul Foster School of Medicine, El Paso, TX, said in a news release, “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.”

Officials said that both inhalers are slated to launch later in 2017. AirDuo RespiClick would be available in 55/14mcg, 113/14mcg, and 232/14mcg strengths, and ArmonAir RespiClick would be available in 55mcg, 113mcg, and 232mcg strengths.