Frequent readers will know that Proteus Digital Health has been testing a wearable skin patch that monitors compliance with drug protocols. At last, three years after announcing the alliance, Proteus and its partner Otsuka have submitted for FDA approval an instrumented version of the anti-depressant Abilify. Although Proteus’s Digital Health Feedback system had already been cleared, this is the first pairing of the system with a drug.
The ingestible sensor will work with the skin patch to monitor dosing patterns as well as physiological responses to the drug; the sensor will be able to send that information to a patient’s doctor.
MobiHealthNews reports that the application was made as a new drug, rather than as a medical device, although both Abilify and Proteus have been OK-ed individually. Also, the site notes that Proteus’s clearance was updated this summer to let the company market its ability to track compliance with medication instructions.