Propeller Health receives FDA clearance for inhaler meds platform

January 6, 2016

2 Min Read
Propeller Health receives FDA clearance for inhaler meds platform

Pharmaceutical & Medical Packaging News staff

Propeller Health announced the FDA cleared its Propeller platform to market in association with medications using GlaxoKlineSmith’s Diskus dry powder inhaler device for asthma and chronic obstructive pulmonary disease (COPD). The clearance follows 510(k) clearance to market the Propeller platform in association with medications using Boehringer Ingelheim’s Respimat inhaler for COPD received in March 2015.

"Poor adherence to inhaled medications remains a common barrier to successful management of respiratory disease,” says David Mannino, MD, professor of medicine in the Division of Pulmonary, Critical Care, and Sleep Medicine at the University of Kentucky, in a released statement. “Propeller has demonstrated that engagement with their platform can change this, doubling adherence and providing significant clinical benefit.” 

Propeller is an FDA-cleared digital health platform designed to help patients and their physicians better understand asthma and COPD, and help to improve the symptoms and outcomes of chronic respiratory diseases.

“I'm encouraged by the potential of combining digital services with existing therapies to improve outcomes,” Mannino says. “Adding these important medications to Propeller's system will help improve care for many patients with COPD and asthma across the US."

With proprietary sensor technology, software, and services, Propeller's platform remotely monitors use of inhaled rescue and controller medications in asthma and COPD, analyzes patient trends, and provides regular feedback. The Propeller system has FDA-granted claims to increase adherence to therapy, predict oncoming exacerbations, and help reduce the frequency of symptoms and exacerbations in asthma and COPD.

According to Propeller, patients with asthma or COPD in more than 35 commercial programs have used its health system across the United States, including major healthcare systems, payers, employers, and other commercial partners. 

"Today we're excited to announce back-to-back FDA clearances that demonstrate our leadership and commitment to a singular goal: moving the field of respiratory health forward," says David Van Sickle, CEO and co-founder of Propeller. "510(k) clearance of our platform with inhaler devices from leading global respiratory companies GlaxoSmithKline and Boehringer Ingelheim opens the door for millions of patients to expect and achieve something better in asthma and COPD." 

Under the 510(k) clearances announced today, the Propeller system can now be used in association with medications delivered by Boehringer Ingelheim's Respimat device (such as Spiriva Respimat, Combivent Respimat, Striverdi Respimat, Stiolto Respimat) and dry powder inhaler (DPI) medications utilizing GlaxoSmithKline's Diskus device (such as Advair Diskus, Flovent Diskus, Serevent Diskus). 

The installed base of the Diskus device in the United States is significant, claims Propeller. According to IMS Health, physicians in the U.S. wrote 14 million prescriptions for Advair in 2014, representing 54.5 percent of the market for combination inhaled corticosteroid/long-acting beta agonist (ICS/LABA) products. Respimat is the platform inhaler for the Boehringer Ingelheim respiratory therapies, which include Spiriva and recently FDA-approved, Stiolto. According to Propeller, Respimat is the only inhaler that actively delivers a slow-moving mist that helps patients inhale the medication.

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