According to Adherium, the FDA has okayed over-the-counter (OTC) sales of the company’s Smartinhaler sensor for AstraZeneca’s Symbicort MDI. The 510(k) OTC clearance will allow patients to purchase the sensor without a prescription at local pharmacies or online.
In 2015, Adherium announced that it had partnered with AstraZeneca to provide sensors for use in the company’s COPD and asthma patient support programs. The SmartTouch sensor initially received 510(k) clearance for use with the Symbicort MDI in September 2017.
Adherium CEO Arik Anderson commented, “Over-the-counter sales of our Smartinhaler sensor for the Symbicort aerosol inhaler continues the advance of our vision for stronger partnerships between patients and physicians by making adherence to personal management plans easier. We are now well positioned to launch in the US, following successes in Europe and Australia. We are providing clinically-proven monitoring to support patients in adopting their physicians’ guidance into their daily lives, and so close the gap between science and real-world care.”
Read the Adherium press release.
