The “Beyond the Pill” movement marked a major milestone with the FDA’s acceptance of the first digital medicine-New Drug Application. It will pair Proteus Digital Health’s ingestible sensor platform with Otsuka Pharmaceuticals’ FDA-approved Abilify drug to treat people with schizophrenia, bipolar disorder and in some cases for major depressive disorder to monitor adherence.
The Abilify tablet contains an ingestible sensor that communicates with a wearable sensor patch and medical software application. The idea is to measure adherence.
Otsuka CEO for development and commercialization Dr. William Carson said in a statement that patients suffering from severe mental illnesses struggle with adhering to or communicating with their healthcare teams about their medication regimen, which can greatly impact outcomes and disease progression.
The technology behind the embedded sensor is pretty cool. Stomach juices activate an energy source — similar to a potato starch battery. The embedded sensor sends signals to a skin patch electrode, which wirelessly transmits information such as vital signs, body position and verification of medication ingestion.
The sensor would be embedded during the drug manufacturing process as a combination drug-device, communicating with the Proteus patch and relevant medical software. If approved, the combination drug-device could be used to tailor medicines more closely to reflect each of our medication-taking patterns and lifestyle choices, Andrew Thompson, Proteus Digital Health CEO said in a statement.