FDA Approves First Pill That Tracks If You've Swallowed It

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 sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet. Proteus Digital Health

The U.S. Food and Drug Administration has your back, approving the first digital tracking pill in the country.

Abilify MyCite, an atypical antipsychotic, is indicated in adults for the treatment of schizophrenia, for the treatment of acute manic and mixed episodes, and maintenance treatment of bipolar I disorder as monotherapy, and as adjunctive therapy to lithium or valproate, and the adjunctive treatment of major depressive disorder.

The device works by transmitting a message from the pill to a wearable patch, which then sends the data to a smartphone app, so that patients can keep track of their medication intake personally. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

"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.

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Abilify is a drug developed by Otsuka Pharmaceuticals whereas the sensor was created by a company called Proteus Digital Health.

Schizophrenia is a chronic, severe and disabling brain disorder, and its symptoms include hearing voices, believing other people are reading their minds or controlling their thoughts, making them suspicious or withdrawn. If a patient opts to allow it, the patient's caregivers and doctor can access the data online, too. "Our rollout of the Abilify MyCite system will be done in phases to obtain, and respond to, feedback from healthcare providers and their patients". The Boxed Warning also warns that if children, adolescents and young adults mix antidepressants and Abilify MyCite, it will increase their risk of suicidal thinking and behavior. While the rates at which patients deviate from their treatment regimens vary, estimates hold such actions cost the USA healthcare system hundreds of billions of dollars each year. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients. Abilify MyCite must be dispensed with a patient medication guide that describes important information about the drug's uses and risks. The common adverse events associated with the sensor were related to the patch, and were predominantly skin irritation.

Applying technology directly into the medicines themselves is a more cutting-edge approach, but one that is clearly gaining traction, as evidenced by the FDA's approval of Abilify MyCite (aripiprazole tablets with sensor).

Andrew Thompson, President and CEO of Proteus Digital Health, says, "The time is right for the category of digital medicines to be available to appropriate patients with serious mental illness".

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