Washington, D.C. -- The FDA announced exciting news this month. After previous rejections, they’ve green-lighted a pill with a built-in sensor to track adherence and compliance. The treatment from Otsuka Pharmaceutical Co. is called the Abilify MyCite system. It combines Abilify and an ingestible sensor produced by Proteus Health to treat schizophrenia, bipolar disorder and depression.
The ingestible sensor itself is a tiny microchip that is attached to or manufactured in a pill. It activates upon contact with stomach acid and sends a message to a tiny patch to confirm it’s been taken. A smartphone app picks it up from there – showing both patient and caregiver how consistently the medication is being taken.
The app can’t make a user take the drug, but it can provide transparency into real-life trends. Meaning, patient and family can start new conversations about why doses are missed and potentially find new, personal solutions.
We started covering Proteus in 2012 when its trials with metformin suggested a game-changing ability for doctors and patients to talk about chronic disease in real life. However, the cost of the technology made it prohibitive for the generic drugs that are often the first-line of treatment for chronic disease and the industry shift to more injectable and specialty drugs made it less relevant for recent major launches.
Abilify shows what will likely be the first clear use cases – life critical medications in categories that are both caregiver-engaged and likely to have multiple-medication routines.
Why this matters
- This decision reflects another step by the FDA to declutter its process to review innovative medicines and devices. This Fall, it announced the participants in its Pre-Cert (precertification) for Software Pilot Program. The involved companies – including Apple, Fitbit, Samsung, Verily, Johnson & Johnson and Roche – will not need to provide the same level of pre-market data for each new digital health product, with some ‘low risk’ tools not needing any pre-market data at all.
- Healthcare is making an important shift from telling people what they should do to understanding what you, as an individual, really do do. With that shift will come a new expectation for support that’s personal, customizable and practical.
- The challenge for all chronic disease is: you have to fight it every day. Inconsistency steals control and shortens the time to the next, inevitable conversation about progression. Technologies like these can potentially stand in the gap.
Read more about the approval at PharmaPhorum.