Adherium receives FDA grant to market Smartinhaler in the US

Medical device manufacturer Adherium (ASX: ADR) has secured a crucial go-ahead decision from the Food and Drug Administration (FDA) in the US.

Earlier today, Adherium was granted 510(k) clearance for over-the-counter (OTC) sales of its Smartinhaler sensor for AstraZeneca’s Symbicort aerosol asthma inhaler. The devices and accompanying technology address sub-optimal medication use and strive to improve health outcomes in chronic disease.

Obtaining the green light for OTC sales of its Smartinhaler SmartTouch for Symbicort means Adherium can now sell its products directly to US consumers nationwide, including through pharmacies and online vendors with no restrictions and without patients requiring a prescription.

Investors reacted very positively to the grant, by buying up Adherium shares and taking its valuation ~45% higher, with its shares trading close to $0.18 per share just before market close.

The market reaction is also likely to be welcomed by Adherium’s board of directors, most of whom chose to invest various sums into the company earlier this month.

Working smarter not harder

The Smartinhaler sensor is a device that attaches onto a patient’s inhaler to monitor and promote asthma and COPD medication adherence, as part of a self-management plan that can be carried out by patients directly, thereby helping to reduce the number of missed medication and to create better patient outcomes.

Adherium is developing a novel method of introducing drug treatments to patients and intends to make its Smartinhaler range available on a wider scale, backed up by strong study results and over a dozen peer-reviewed studies done by the likes of The Lancet and the University of Auckland.

“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,” said Arik Anderson, CEO of Adherium.

“We are now well positioned to launch in the U.S., 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,” Mr Anderson said.

Adherium says its next-generation Smartinhaler sensor can record the date and precise time the inhaler is used and to automatically transmit such information to an application on the patient’s phone or tablet. All information is stored including the detailed history of patient medication usage patterns, thereby allowing physicians to review the data at a later date (or in real-time) to make evidence-based decisions.

According to Adherium, its devices have been built to simplify and improve how patients schedule their medication intake, especially on a regular and prolonged basis when patients are at most danger of straying from pre-set medication schedules.

One of its key features is its inherent sensor design which includes three buttons allowing patients simplified access to audio-visual reminders, battery monitoring and wireless Bluetooth connectivity.

Today’s grant now paves the way for Adherium’s long-awaited consumer launch and helps to garner greater support of AstraZeneca’s Symbicort drug in the US.