The ProAir Digihaler, a digital inhaler that allows patients with asthma and chronic obstructive pulmonary disease (COPD) to track their inhaler usage through a mobile app, has been approved by the U.S. Food and Drug Administration (FDA), its developer Teva Pharmaceuticals announced.
Albuterol is a short-acting beta-agonist bronchodilator that can relieve COPD-related symptoms such as bronchospasms. Sometimes called a rescue-inhaler, albuterol works by relaxing the smooth muscle cells of the bronchi, and opening up airways.
Since patients take the medication when needed, and often in parallel with prescribed long-term daily treatments, its improper use is a concern.
“Despite advancements in care over the years, we know that many are using their rescue medications incorrectly or too often,” Tonya Winders, MBA, president and CEO of the Allergy & Asthma Network, said in a news release.
The ProAir Digihaler is a combined breath-activated, multi-dose albuterol inhaler with built-in sensors, designed to record and store data on the administration of the medicine, and upload it via Bluetooth to an associated mobile app. The device will allow COPD and asthma patients to review and also share their data with healthcare professionals.
Its approval by the FDA “marks a significant milestone not only for Teva, but for the respiratory community as it allows patients and their caregivers to better understand inhaler usage through digital technology,” said Sven Dethlefs, Teva’s executive vice president of Global Marketing & Portfolio.
“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,” Dethlefs added.
The inhalers will be available in 2019, through a small number of “Early Experience” Programs, which will be conducted in partnership with healthcare systems and in limited areas. Teva plans a nationwide launch of the digital inhaler in 2020.
“One of the challenges physicians are faced with in caring for their asthma and COPD patients is knowing if their patients are using their inhaled medication as they should,” said Tushar Shah, MD, senior vice president of Global Specialty Clinical Development at Teva.
“Offering a tool that enables doctors to see data on their patients’ inhaler usage will allow them to have more productive conversations about identifying issues and how to manage their illness,” Shah added.