Teva Receives FDA-Approval for Smartphone-Linked Digital Inhaler

Teva Pharmaceutical Industries has recently received FDA-approval for their one-of-a-kind digital inhaler with built in sensors and companion mobile app. Named ProAir Digihaler, the device uses albuterol in a breath-activated dry powder inhaler with sensors that detect when the inhaler is being used and measure inspiratory flow. A Bluetooth chip in the inhaler allows the user to view this data in the mobile app and review with their physician.

“This approval 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, EVP of global marketing and portfolio at Teva.

ProAir Digihaler was designed for treatment and prevention of bronchospasm in patients of at least age four with asthma or COPD, and can help prevent exercise-induced bronchospasms as well. Teva claims the digital inhaler will be available this year through a handful of “Early Experience” programs that will be carried out as partners with healthcare systems and in limited areas as well. Teva stated that the national launch is planned for 2020, and that these early releases will serve as a means of gathering data.

READ MORE: Asthma-COPD Overlap: What Is Known and What Is Not

“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,” said Tushar Shah, M.D., Teva SVP of global specialty clinical development.

The news of this FDA-approval comes nine months after Adherium’s SmartinhalerTm sensor received 510(k) clearance from the FDA. This sensor works with AstraZeneca/’s Symbicort aerosol asthma inhaler, and is installed into the patient’s inhaler to promote and monitor asthma and COPD medication adherence. Similar to ProAir Digihaler, Smartinhaler also records dates and times of inhaler use and translates this data to an app. Digital inhalers such as these follow the trend of incorporating convenient technology into therapeutic devices that have long been in use.

“The FDA approval of ProAir Digihaler is significant because it may help patients track their inhaler usage and provide data that can be used to work more closely with their HCPs on their asthma management,” claimed Tonya Winders, president and CEO of the Allergy & Asthma Network. “This approval is a major step forward and is indicative of how medications are evolving through technological innovations.”

READ MORE: Guidance for Identifying Severe Asthma

The Center for Disease Control and Prevention reported in 2016 that roughly 26.5 million Americans are living with asthma, and around 1.7 million emergency department visits resulting from asthma symptoms occurred in 2015. With asthma management being largely in the hands of the patient, devices that bolster medication adherence are imperative to improve outcomes. Incorporating this smartphone linked software into the inhaler not only keeps the device at pace with evolving technology, but helps monitor adherence and correct errors with treatment dispensing as well.

“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. That’s what makes a product like this so important to doctor-patient discussions,” said Shah. “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.”

Sources: Genengnews, MobiHealthNews