US regulators approve first digital pill to track patients

Wednesday, 15 November 2017, 12:25:26 AM. Abilify MyCite is the first drug approved in the US with a digital ingestion tracking system to ensure that patients take their medicine.
WASHINGTON — U.S. regulators have approved the first drug with a sensor that can track whether patients have taken their medicine. The Abilify pill was first approved by the Food and Drug Administration in 2002 to treat schizophrenia, and the sensor technology was approved for marketing in 2012. The FDA said in a statement Monday that 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,” Dr. Mitchell Mathis of the FDA said in statement. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how this technology might benefit patients and prescribers.” Abilify MyCite was developed by Otsuka Pharmaceutical Co. and the sensor was created by Proteus Digital Health. Greenlighting the new digital version, however, came with some caveats. While the system can track doses, it hasn’t been shown to improve patient compliance, the FDA said. “Abilify MyCite should not be used to track drug ingestion in ‘real-time’ or during an emergency,” the statement said, “because detection may be delayed or may not occur.” Patients can track their dosage on their smartphone and allow their doctors or caregivers to access the information through a website. In a statement issued last May at the time the FDA accepted submission of product for review, the companies said...Read more
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