Proteus Digital Health
The Food and Drug Administration has approved its first digital drug: a pill embedded with a sensor that transmits whether someone has taken it.
Although the approval is a big step for digital medicine, there are concerns about privacy, convenience and cost.
The tablet and embedded sensor is called Abilify MyCite. Abilify, made by Japan-based Otsuka Pharmaceutical, is the brand-name version of aripiprazole, an antipsychotic drug used for treating schizophrenia, bipolar disorder and as an add-on treatment for depression in adults.
The tiny sensor, made by a company called Proteus, is about the size of a grain of sand. It’s activated when it comes into contact with fluid in the stomach. The sensor detects and records the date and time the pill is ingested.
The sensor transmits that data to a patch worn by the patient. The patch then sends the data to a smartphone application; the data can then be shared with selected family members or caregivers.
That’s a lot of moving parts, but the problem it aims to address is a real (and expensive) one: nonadherence, which is the term for patients not following through with prescribed treatment. Nonadherence is a problem for people with many kinds of health issues, such as hypertension and high cholesterol.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center…