Digital Maintenance Asthma Inhaler Therapy Gets FDA Approval

AirDuo Digihaler
AirDuo Digihaler
The FDA has approved the AirDuo Digihaler for the treatment of asthma in patients aged 12 years and older.

The Food and Drug Administration (FDA) has approved the AirDuo Digihaler (Teva Pharmaceuticals) for the treatment of asthma in patients aged 12 years and older.

AirDuo Digihaler is a combination of fluticasone propionate, a corticosteroid, and salmeterol, a long-acting beta2-adrenergic agonist (LABA). It should be used in patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and LABA. 

The product contains a built-in electronic module which detects, records, and stores data on inhaler events, including peak inspiratory flow rate (L/minute), for transmission to a companion mobile application (using Bluetooth Wireless technology) where inhaler events are categorized. Using the app, patients can then review and share data with their healthcare providers, as well as schedule dosing reminders; use of the app is not required for administration of AirDuo Digihaler. 

Commenting on the approval, Dr Nabeel Farooqui, MD, FAAAAI, FACAAI, Assistant Professor, Department of Medicine, Indiana University School of Medicine said, “The ability to now measure [patient] inspiratory flow rates and track their maintenance medication use, as well as the frequency with which they use their inhaler, may provide important data and insights to help inform treatment discussions with physicians.”

AirDuo Digihaler, an inhalation-driven, multidose dry powder inhaler, will be supplied in 3 strengths: 55/14mcg, 113/14mcg, and 232/14mcg; each inhaler provides 60 actuations. The product is expected to be available in 2020.

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This article originally appeared on MPR