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USA approves first pill with digital tracking device
14 November 2017, 08:08 | Melissa Porter
The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet. Proteus Digital Health
The Food and Drug Administration has approved for the first time a drug embedded with a digital sensor that can tell patients, caregivers and physicians when it has been taken. Approval of Abilify MyCite (aripiprazole tablets with sensor) comes as its manufacturer, Otsuka, is also marketing its once-a-month version of the therapy, which is approved for both schizophrenia and bipolar I disorder, 2 of the most debilitating mental health conditions.
"It is important to note that Abilify MyCite's prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown", the FDA said in the November 13 statement.
Abilify MyCite's labeling information also notes the product's ability to improve treatment compliance in patients has not been proven.
Proteus has been working on the digital pill for years, and the tracking sensor was first approved for use by the FDA in 2012.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, said in his statement on Abilify MyCite.
The sensor technology and patch are made by Proteus Digital Health, and are approved for use with existing medications in the United States and Europe.
Would you ingest a digital pill that allows you to conveniently track when you took the medication - and possibly allow others to track it as well? The system is meant to integrate into individuals' lives, and individuals indicate through the app which member (s) of their care team can access information about their medication ingestion, activity, and self-reported mood and rest. The hope is to provide additional clarity to better inform decision-making for physicians and their patients.
According to Higuchi, the Abilify MyCite will be rolled out in phases to allow them to gather and respond to feedback provided by patients and health care providers.
The tracking system provides a way for doctors to objectively measure if patients are sticking to their medication schedules, opening doors for monitoring medicine intake methods in other areas of medicine and health care. Consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smartphones, as they go about their daily lives.
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