WASHINGTON (AP) – The Food and Drug Administration has approved the first drug in the United States with a digital ingestion tracking system in an
unprecedented step to ensure that patients with mental disorders take the medicine prescribed for them.
The drug Abilify MyCite was developed by Otsuka Pharmaceutical Co., Ltd.
Abilify was first approved by the FDA in 2002 to treat schizophrenia, and the ingestible sensor, made by Proteus Digital health, was initially approved for
marketing in 2012.
The agency says the digitally enhanced medication “works by sending a message from the pill’s sensor to a wearable patch.”
Dr. Mitchell Mathis of the FDA says officials support “use of new technology in prescription drugs and is committed to working with companies to understand
how the new technology might benefit patients and prescribers.”