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FDA approves first 'trackable' pill Abilify

First approved back in 2002 by the FDA to treat schizophrenia, the Abilify pill works by 'sending a message from the pill's sensor to a wearable patch'

14 November 2017, 4:48pm
(Photo: Netdoctor)
(Photo: Netdoctor)
US regulators have approved the first pill with a sensor, which can track whether or not patients have taken their medicine.

The Abilify pill was first approved by thee Food and Drugs Administration (FDA) back in 2002, to treat schizophrenia and the sensor technology was approved for marketing in 2012.

In a statement on Monday, the FDA said that the digitally-enhanced drug “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”, said Dr Mitchell Mathis, of the FDA.

“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.”

The drug was developed by Otsuka Pharmaceutical co. and the sensor by Proteus Digital Health.

There were some issues, however, with green-lighting the new digital version as while the system can track doses, it hasn’t been shown to improve patient compliance, said the FDA.

“Abilify MyCite should not be used to track drug ingestion in ‘real-time’ or ‘during an emergency”, said the statement, “because detection may be delayed or may not occur.”

Patients would be able to track their dosage on their smartphone and allow their doctors access through a website.

In a statement issued in May, when the FDA accepted the submission of the product for review, the company said “with the patient’s consent, this information could be shared with their healthcare professional team and selected family and friends, with the goal of allowing physicians to be more informed in making treatment decisions that are specific to the patient’s needs”.

The sensor “activates when it reaches stomach fluids and communicates with the patch”, said the company.

According to the FDA, the Abilify has been approved for the treatment of schizophrenia and bipolar disorder, as well as an add-on treatment for depression.

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