The treatment is called Abilify MyCite, which is meant to treat schizophrenia, acute treatment of manic and mixed episodes associated with bipolar disorder, and for use as an add-on treatment for depression in adults. This is picked up by a wearable patch-worn on the left rib cage and replaced after seven days-which then sends the information to a smartphone app that allows patients to track when they took their medication.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Dr. Mitchell Mathis, director of the agency's Division of Psychiatry Products.
But until now, the FDA had not approved a sensor-pill combination.
The information can also be accessed by caregivers and physicians through a web-based portal, but patients have to grant access. Labeling information stresses that it has not been proven if tracking such information improves treatment regimens.
"Abilify MyCite should not be used to track drug ingestion in "real-time" or 'during an emergency", said the statement, "because detection may be delayed or may not occur".
Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks.
Aripiprazole is approved with a Boxed Warning concerning an increased risk of death when used as a treatment for elderly patients with dementia-related psychosis.
The system in the drug offers an objective way to measure whether patients have taken their pills on schedule, which opens up new ways to monitor treatment compliance that can be applied in other therapeutic cases. A report from the IMS Institute for Healthcare Informatics estimates that the cost of patients not taking their medication correctly is about $100 billion each year.
The FDA-approved pill, Abilify MyCite, consists of aripiprazole tablets, but with a sensor.
The technology is the product of research between Japanese pharmaceutical company Otsuka and Proteus Digital Health, and is created to solve the problem of people missing medicine doses, which costs the US healthcare system an estimated $200 billion per year.