Proteus Digital Health Files FDA Application To Embed Sensors In Anti-depression Medications


Proteus Digital Health has submitted a New Drug Application with the FDA seeking clearance for it to begin embedding its digital medicine sensor into actual pills, rather than in the placebos that its FDA clearance currently permits. The announcement marks a major milestone for Proteus, which launched in 2001 with the goal of developing small sensors that would be embedded in prescription drugs to help patients, providers, and caregivers monitor a patient’s medication adherence rates. The sensor that Proteus ultimately designed is remarkable in a number of ways. The sensor has no battery, radio, or antenna, but none-the-less is able to detect when it has been swallowed, and then transmit a signal from within the stomach to a Bluetooth-enabled patch that updates a smartphone-based medication adherence app. Collectively, the platform represents one of the first truly passive monitoring systems attempting to tackle poor medication adherence rates, a problem that is estimated to cost between $100 and $300 billion in healthcare spending annually in the US.

Since finalizing the design of its platform, Proteus has been pushing for regulatory approval to begin selling its sensors to pharmaceutical companies, but the FDA and European regulators have been reluctant to green light the technology. Proteus initially received FDA approval to market its sensors as a medical device designed to track medication adherence. In that platform, the sensors are embedded in placebos and patients are told to take the placebo in conjunction with their active medications. While this does offer an effective means of measuring adherence, it does not leave Proteus with a product it can market to pharmaceutical companies.

Now, three years after announcing a partnership with Otsuka Pharmaceuticals, makers of the anti-depression medication Abilify, the two organizations have submitted an application to the FDA seeking approval to "embed the FDA-approved Proteus sensors into Otsuka’s FDA approved medications. If approved, Abilify will be the first pharmaceutical manufactured with embedded sensors and an entire passive medication adherence platform supporting its customers. The target processing time for a New Drug Application to be reviewed is 10 months, according to the FDA, though historically this timeframe can take much longer. However, Proteus has been working closely with the FDA for years and a decision should be published sometime next year.

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