FDA Approves Drug With Digital Ingestion Tracking System
WEDNESDAY, Nov. 15, 2017 -- The first drug in the United States with a digital ingestion tracking system has been approved by the U.S. Food and Drug Administration.
Abilify MyCite consists of aripiprazole tablets with an embedded sensor in each that sends a message to a wearable patch when the medication been taken. This allows the patients to track medication ingestion via smartphone, and they can also permit their physicians and caregivers to access the information through a web-based portal.
Abilify MyCite hasn't been proven to improve patient compliance with a treatment regimen, the FDA said in a news release. And the drug should not 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 includes a boxed warning that elderly people with dementia-related psychosis have an increased mortality risk if they take the medication, the FDA said. The label also warns of increased risk of suicidal ideation among children, adolescents, and young adults.
Abilify MyCite's approval was granted to Japan's Otsuka Pharmaceuticals Co. The sensor technology and patch are made by Proteus Digital Health in Redwood City, California.
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Posted: November 2017