Adherium announced that the Food and Drug Administration (FDA) has granted clearance for the over-the-counter (OTC) sale of the Hailie sensor (previously known as Smartinhaler) for expanded use with ProAir HFA (albuterol sulfate; Teva), Ventolin HFA (albuterol; GlaxoSmithKline), and Flovent HFA (fluticasone propionate; GlaxoSmithKline) inhalers.
Prior to today’s FDA clearance, the Hailie platform was intended for use with Symbicort (budesonide, formoterol fumarate dihdyrate; AstraZeneca). The Hailie sensor attaches to the asthma or chronic obstructive pulmonary disease (COPD) inhaler to monitor and help with patient adherence. The device tracks medication use, provides a usage history, and reminds the patient when it is time to take a dose.
ProAir HFA and Ventolin HFA are beta-2 agonists indicated to treat bronchospasm in patients aged ≥4 years. Flovent HFA is a steroid indicated for maintenance treatment of asthma as prophylactic therapy in patients aged ≥4 years.
An online portal will be available for healthcare professionals to access patient-group data and reports from the Hailie sensors. Through Bluetooth technology, clinicians and patients will be able to share and monitor inhaler usage.
For more information visit Hailie.com.