The Food and Drug Administration has approved the first drug in the United States with a digital ingestion tracking system, in an unprecedented move to ensure that patients with mental illness take the medicine prescribed for them.
The drug Abilify MyCite, developed by Otsuka Pharmaceutical Co. Ltd, was first approved by the FDA in 2002 to treat schizophrenia.
The ingestible sensor, made by Proteus Digital health, was approved for marketing in 2012.
The digitally enhanced medication works by sending a message from the pill's sensor to a wearable patch.
Being able to track ingestion of medications prescribed for illness may be useful for some patients.
Abilify MyCite's labelling asserts the ability of the product to improve patient compliance with their treatment regimen has not been shown.
Abilify MyCite should not be used to track drug ingestion in 'real-time' or during an emergency because detection may be delayed or may not occur.
In a portion of the statement to address privacy concerns, the FDA said the wearable patch that comes with the medication "transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone.
Patients can also permit their caregivers and physician to access the information through a web-based portal.
Proteus Ingestible sensor "activates when it reaches stomach fluids and communicates with the patch."
The product is designed for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with a bipolar disorder and for use as an add-on treatment for depression in adults.