First Digital Inhaler With Built-In Sensors Gets FDA Approval

Teva announced that the Food and Drug Administration (FDA) has approved ProAir Digihaler (albuterol sulfate) inhalation powder for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older. The approval was based on the review of a supplemental New Drug Application (sNDA). 

ProAir Digihaler is the first digital inhaler with built-in sensors that connects to a mobile application and provides data on inhaler use to patients with asthma and chronic obstructive pulmonary disease (COPD). The product combines a breath-activated, multi-dose dry powder inhaler with albuterol along with a built-in electronic module and a companion app. The sensors detect and record when the inhaler is used and measure inspiratory flow; this data is then sent to the companion application via Bluetooth Wireless Technology so patients can review their data and share it with their healthcare professionals. 

“The digital technology built into ProAir®Digihaler™ provides patients with data on their inhaler use, which may help them to have a more informed dialogue with their healthcare provider regarding their asthma or COPD management,” stated Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio. 

ProAir Digihaler will be supplied as a breath-actuated dry powder inhaler that meters 117mcg of albuterol sulfate from the device reservoir (108mcg from the mouthpiece) per actuation; the inhaler contains 200 actuations. It will be available in 2019 through several “Early Experience” Programs in order to compile real-world data. A national commercial launch is anticipated in 2020. 

For more information call (888) 483-8279 or visit ProAirDigihaler.com.