FDA approves first 'trackable' pill Abilify

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 US Food and Drug Administration has approved aripiprazole tablets with a sensor to digitally track whether patients have taken their medication (Abilify MyCite).

Called Abilify, the purely chemical version of the drug actually received FDA approval over a decade ago to treat patients with schizophrenia and bipolar disorders.

The system works by sending messages from a pill sensor to a usable patch material, which then transmits the information to the mobile app so that patients can track drug consumption on their smart mobile phone.

Dr. Mitchell Mathis of the FDA says officials support "use of new technology in prescription drugs and is committed to working with companies to understand how the new technology might benefit patients and prescribers".

Should prescribes take to Abilify MyCite, the new formulation could help Abilify's maker Otsuka Pharmaceutical Co. Ltd.

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.

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Using an app on their smartphone, patients can keep track of their dosage and allow their physicians to access information through a website. The pill is created to track if patients are taking their medication.

Not necessarily. Abilify MyCite notes under its label that the product's ability to improve patient compliance with their treatment regimen has not been shown.

Elderly patients with dementia-related psychosis treated with antipsyhotic drugs, such as Abilify MyCite, are at an increased risk of death. Other warnings include an increased risk of possible suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. A report from the IMS Institute for Healthcare Informatics estimates that the cost of patients not taking their medication correctly is about $100 billion each year.

Abilify MyCite's future isn't certain, however.

In the case of Abilify, a patient who doesn't stick to the drug could end up in a psychiatric hospital, so Abilify MyCite may find its niche. In Abilify MyCite, skin irritation at the site of the MyCite patch may also occur.

The application for aripiprazole with the embedded sensor was originally accepted by the FDA for review in September 2015, which was followed by a complete response letter requesting more information on the digital drug. The technology in the sensors and the patch were developed by Proteus Digital Health.

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