First Digital Albuterol Inhaler Approved
December 21, 2018 – The U.S. FDA has approved ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, manufactured by Teva Pharmaceuticals. It is indicated to treat or prevent bronchospasm in patients who are at least four years of age and have reversible obstructive airway disease, as well as to prevent exercise-induced bronchospasm (EIB) in patients who are four years old and up.
The ProAir Digihaler is the first digital inhaler that allows patients and caregivers to track albuterol use. Sensors detect when a patient uses the inhaler and measure the inspiratory flow of medication. The Digihaler transmits this data to a mobile app, where users can review the information. This may help them understand if they are using their inhaler too often or incorrectly. Before making any changes to their medication use, patients should speak to their prescriber. They can share the information collected by the Digihaler and its app with their healthcare provider.
Albuterol sulfate, the active ingredient in the ProAir Digihaler, has been FDA approved for more than thirty years. It can be used as a rescue drug to provide quick-acting relief from bronchospasms, and as a maintenance treatment to prevent bronchospasms. Albuterol opens breathing passages by relaxing the muscles of the airway, and is available under several brand names, including other ProAir products.
Teva plans to make the ProAir Digihaler available in 2019 through a limited number of “Early Experience” programs. The product is expected to be available nationally in 2020. Pricing plans have not been announced.