March 23, 2018

FDA approves smart pill that lets doctors know when it's been swallowed

14 November 2017, 08:04 | Kevin Scott

The pill and its digital companions, now FDA-approved as Abilify MyCite, aren't likely to make a big difference to Otsuka's Abilify sales-certainly not immediately, given its plans for a limited initial launch.

The treatment intends to address issues with patients taking their medication correctly.

U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.

"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.

Always forget if you've taken your medication?

Tatsuo Higuchi, President and Representative Director of Otsuka Pharmaceutical Co., Ltd., remarks, "This approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies".

The companies said the sensor "activates when it reaches stomach fluids and communicates with the patch".

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Aripiprazole was initially approved by the FDA in 2002 as a treatment for patients with schizophrenia. But the new product will also be labeled with a caveat: There's no evidence that the technology can help patients take their medication as prescribed. If a patient opts to allow it, the patient's caregivers and doctor can access the data online, too.

The system has three main components: the pill itself, a patch that detects and records the time and date the pill was ingested and tracks other physiological data, and a smartphone app that allows gathered data to be viewed.

"Being able to track ingestion of medications prescribed for illness may be useful for some patients", said Dr Mitchell Mathis, of the FDA.

The Otsuka website notes, "It can take 30 minutes to 2 hours to detect ingestion of the tablet". 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.

A small pilot study earlier this year, involving researchers from the University of Massachusetts Medical School in Worcester, as well as researchers from a number of Boston hospitals including Massachusetts General, Brigham and Women's and Beth Israel, involved the use of "digital pills to measure opioid ingestion patterns in emergency department patients with acute fracture pain".

In the longer term, such digital pills could also be used to manage patients with other complicated medicine routines, such as those suffering from diabetes or heart conditions.

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