FDA News

New digital inhaler receives FDA approval for patients with asthma

The FDA has approved a combination therapy digital inhaler for treatment of asthma in patients aged 12 years and older, according to a manufacturer press release.

The AirDuo Digihaler inhalation powder (Teva Pharmaceuticals) combines fluticasone propionate and salmeterol in a digital inhaler with built-in sensors that connect to a mobile application to provide information on inhaler use.

Similar to the company’s ProAir Digihaler inhalation powder, which is indicated for treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease, the sensors in the new combination therapy digital inhaler can detect when the inhaler is used and measure inspiratory flow rates. Patients can then review their data over time, share with their heath care providers and set reminders to take their medication.

“Even the most diligent asthma patients may not realize they are not following their treatment regimen, despite their best efforts,” Nabeel Farooqui, MD, FAAAAI, FACAAI, assistant professor in the department of medicine at Indiana University School of Medicine, said in the release. “The ability to now measure their 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. As a doctor, it’s exciting that my patients are able to share this type of information with me.”

The FDA approved the AirDuo Digihaler in doses of 55/14 µg, 113/14 µg and 232/14 µg administered as one inhalation twice daily, and the device is expected to be available to patients with a prescription by 2020, according to the release.

The FDA has approved a combination therapy digital inhaler for treatment of asthma in patients aged 12 years and older, according to a manufacturer press release.

The AirDuo Digihaler inhalation powder (Teva Pharmaceuticals) combines fluticasone propionate and salmeterol in a digital inhaler with built-in sensors that connect to a mobile application to provide information on inhaler use.

Similar to the company’s ProAir Digihaler inhalation powder, which is indicated for treatment or prevention of bronchospasm in patients aged 4 years and older with reversible obstructive airway disease, the sensors in the new combination therapy digital inhaler can detect when the inhaler is used and measure inspiratory flow rates. Patients can then review their data over time, share with their heath care providers and set reminders to take their medication.

“Even the most diligent asthma patients may not realize they are not following their treatment regimen, despite their best efforts,” Nabeel Farooqui, MD, FAAAAI, FACAAI, assistant professor in the department of medicine at Indiana University School of Medicine, said in the release. “The ability to now measure their 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. As a doctor, it’s exciting that my patients are able to share this type of information with me.”

The FDA approved the AirDuo Digihaler in doses of 55/14 µg, 113/14 µg and 232/14 µg administered as one inhalation twice daily, and the device is expected to be available to patients with a prescription by 2020, according to the release.