The first drug designed to alert a doctor when a patient takes the medication has been approved by the U.S. Food and Drug Administration.
Abilify MyCite (aripiprazole with sensor) has an embedded sensor that sends a message to a wearable patch that the medication’s been taken. This allows the patient and doctor to track the medication’s use via smartphone.
Abilify, first approved in 2012, is now OK’d to treat schizophrenia, manic depression and bipolar disorder, the FDA said in a news release.
“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.
Abilify MyCite hasn’t been proven to improve patient compliance with taking medication on a prescribed schedule, the FDA stressed. And the drug shouldn’t be used in an attempt to track “real-time” ingestion since detection could be delayed, the agency added.
As with similar antipsychotic drugs, Abilify MyCite’s label will include a boxed warning that elderly people with dementia-related psychosis are at increased risk of death if they take this medication, the FDA said. The label also warns of increased risk of suicidal thinking and behaviour among children, teens and young adults.
Abilify MyCite’s approval was granted to Japan’s Otsuka Pharmaceuticals. The sensor technology and patch are made by Proteus Digital Health, in Redwood City, Calif.