• 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.

Source:TH