The FDA’s acceptance of the first digital medicine-New Drug Application took place this week.. 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.
Why It’s HOT: Abilify recently went off patent; therefore, generic versions of the medication are now available. To combat the loss associated with LOE, Otsuka partnered with a digital innovation company to be a first mover of a new offering to their pre-existing market; although, with a new intriguing competitive edge and MOA associated with the digestible sensor. There is no chemical reformulation of the drug; it simply now has innovative utility that is sure to drive HCP script writing in light of the generic form of Abilify being available without the digestible sensor because it has the potential improve patient outcomes which is the desired end goal for all suffering from mental illness.