Medicine

FDA Approves Schizophrenia Medication With Digital Ingestion Sensor

FDA Approves Schizophrenia Medication With Digital Ingestion Sensor

USA 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.

The pill, called Abilify MyCite, adds a tiny sensor, no larger than a grain of sand, made of silicon, copper, and magnesium inside a tablet of Abilify, a drug used to treat mental disorders like schizophrenia, bipolar disorder, and is used in conjunction with antidepressants to treat depression.

A patient ingests the pill, and a sensor inside the pill activates when it reaches the stomach fluids, sending a message to a wearable patch.

"The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers", Dr. Mitchell Mathis, director of the division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

The FDA's approval does come with some conditions, though.

Whatever way you look at it, this is a major breakthrough for digital health and we're sure now that the FDA has approved one smart pill, we'll soon be flooded by more of them over the coming years.

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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.

Abilify MyCite is not approved for patients with dementia-related psychosis; it has a Boxed Warning that taking this medication puts patients with dementia-related psychosis at an increased risk of death.

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

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.

Patients taking Abilify MyCite should be monitored for worsening or emerging suicidal thoughts and behaviors. Skin irritation at the site of the MyCite patch placement may occur in some patients. The medication must also be dispensed with a patient Medication Guide with information about the drug's uses and risks. The patch and sensor is manufactured by the company Proteus Digital Health and aripiprazole marketed by Otsuka Pharmaceutical.

The FDA has announced a new approval that marks a first for the agency: Abilify MyCite.