FDA approves Teva’s integrated digital rescue inhaler

Teva has slated the Digihaler for a national launch in 2020. (FDA)

Teva Pharmaceutical Industries has received FDA approval for a fully integrated digital inhaler for patients with asthma and chronic obstructive pulmonary disease, equipped with built-in sensors.

Its ProAir Digihaler, containing albuterol sulfate, connects to a companion smartphone application to track medication usage. It also measures inspiratory flow to gauge how well patients are using their inhaler.

“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, Teva’s senior VP of global specialty clinical development. “That’s what makes a product like this so important to doctor-patient discussions.”

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“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.

The rescue inhaler is indicated for the treatment or prevention of bronchospasm in patients age 4 and older with reversible obstructive airway disease as well as the prevention of exercise-induced bronchospasm.

“There are 25 million Americans living with asthma, many of whom use inhalers as part of their treatment regimen,” Tonya Winders, president and CEO of the Allergy & Asthma Network, said in a statement. “Despite advancements in care over the years, we know that many are using their rescue medications incorrectly or too often.”

The Digihaler will initially be available through limited “early experience” programs in partnership with healthcare systems, according to Teva, with a national launch planned for 2020.

Last October, smart inhaler developer Propeller Health, which offers digital tracking hardware as an add-on for previously approved inhalers, published real-world data from rescue inhalers showing that asthma control guidelines may be outdated. In addition, the sensors were more accurate than a patient’s memory and healthcare provider assessments.

RELATED: ResMed to acquire connected inhaler developer Propeller Health for $225M

While tracking “occasions of rescue use” is recommended by guidelines, there is no clear definition of a single occasion. Propeller Health’s data showed that, within the first two minutes of the first use, 30% of rescue events consisted of a single puff, 53% had two and 17% had three or more, with patterns changing over the following four to six hours.

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