New AirDuo Dosage Form Approved
July 15, 2019 – The U.S. FDA has approved the AirDuo® Digihaler™ (fluticasone propionate 113mcg and salmeterol 14mcg) inhalation powder, manufactured by Teva Pharmaceuticals. A new AirDuo dosage form, the AirDuo Digihaler is indicated to treat asthma in patients who are at least 12 years of age. However, it is recommended only for patients whose asthma is not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease warrants treatment with both an inhaled corticosteroid and a long-acting beta2 adrenergic agonist (LABA).
Through the use of a digital inhaler and a mobile app, the AirDuo Digihaler allows patients to track inhaler use to gain a better picture of their inhaler use. The Digihaler’s built-in sensors detect when the inhaler is used and measures inspiratory flow rates. This data can be tracked with the mobile app and can be shared with the patient’s healthcare providers. Patients can also schedule medication reminders through the app to help support treatment adherence. Information collected by the app may help patients have an informed discussion with their prescriber about their treatment plan.
Recommended dosing is one inhalation twice daily, with the dosage strength based on the patient’s prior asthma therapy and disease severity. The AirDuo Digihaler is available in three dosage strengths: 55/14mcg, 113/14mcg, and 232/14mcg per actuation. Patients should not exceed two inhalations per day, and should not take more than one inhalation at a time.
The AirDuo Digihaler is the second of Teva’s products to gain approval for the use of the Digihaler delivery system. In December 2018, the FDA approved Teva’s ProAir® Digihaler™ (albuterol sulfate 117mcg) inhalation powder, which is indicated to treat or prevent bronchospasm in patients who are at least four years of age and have reversible obstructive airway disease, as well as to prevent exercise-induced bronchospasm (EIB) in patients four years and older.
Teva plans to launch the AirDuo Digihaler in 2020. Pricing plans are not yet available.