US approval for an inhaler monitoring device
Patent Attorney and member of our Medical Devices Industry Team, Alex Bone, reflects on a decision by the US Food and Drug Administration (FDA) to approve an adherence monitoring inhalation device for use in the US.
“During previous employment at Novartis I looked at various medical devices for monitoring adherence, so I was interested to read the recent announcement of a US approval from Adherium Ltd. On 1 September 2017 Adherium announced that it had received 510(k) clearance from the FDA for its inhaler monitoring device, SmartTouch for Symbicort. The device was cleared for use with AstraZeneca‘s Symbicort aerosol inhaler which is used for treatment of asthma and chronic obstructive pulmonary disease (COPD).
The SmartTouch for Symbicort is part of Adherium’s Smartinhaler range of devices and apps developed to help in the management of respiratory conditions. The device attaches to the Symbicort inhaler and logs the time and date of each use. It then transmits that data to an app on a smartphone or tablet. The app can then be used by patients to check that they are correctly following their prescribed treatment plan, and by doctors when considering a change to a patient’s prescription.
This clearance follows a partnership, announced in 2015, under which Adherium agreed to supply AstraZeneca with new devices and sensors for use within its global patient support programs for COPD and asthma. This partnership was apparently the world’s first commercial arrangement combining digital health technology with blockbuster inhaled medications to improve health outcomes for those with respiratory health problems.
Moving towards electronic patient monitoring?
Adherence to a treatment plan is an important part of managing health problems, particularly chronic conditions. Poor adherence is a growing problem around the world, especially in countries with ageing populations. Badly managed conditions can result in unnecessary hospital admissions, which can mean bigger overall healthcare costs. Maintenance treatments for asthma in particular have a poor record, with adherence rates often below 50%.
Electronic monitoring of a treatment plan has been considered desirable for many years and Adherium began working on this technology in 2001. Adherium (Nexus6 at the time) filed their first patent application for a “Reminder For a Medicament Inhaler” a few years later. Twelve further patent applications have been published since then, indicating a continued development effort.
Adherium’s trial results look positive
This ongoing work seems to have paid off: clinical trials have shown that the addition of an Adherium device to an asthma inhaler can increase adherence by up to 59% in adults, and 180% in children. The trials also showed a 60% reduction in severe episodes, which was a significant improvement over best practice at the time.”