The Wall Street Journal: First-ever digital drug gets FDA approval

U.S. authorities approved the world’s first digital drug, an antipsychotic pill that signals smartphones once it reaches the gut so doctors can track whether patients are taking their medication.

Tuesday’s green light from the Food and Drug Administration means Japan’s Otsuka Pharmaceutical Co. can implant a tiny chip containing minerals like silicon, magnesium and copper inside tablets of Abilify, which is used to treat schizophrenia, bipolar disorder and other mental illnesses.

Once swallowed, the chip mixes with stomach acids and sends a heartbeat-like signal to an adhesive patch worn on a patient’s torso. The patch records the dosage and time of ingestion and relays this to a smartphone app for patients to monitor and share with doctors and caretakers. The chip ultimately passes through the digestive tract normally.

Otsuka, whose parent company is Otsuka Holdings Co. Inc. 4578, +0.50%  , spent years testing the drug with Silicon Valley company Proteus Digital Health Inc., which provided the chip technology.

An expanded version of this report appears on WSJ.com.

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