FDA approves Abilify with sensor to track ingestion

SILVER SPRING, Md. — The Food and Drug Administration has approved the first pill to contain a digital ingestion tracking system. The Abilify MyCite (aripiprazole with sensor) tablets — a collaboration between Otsuka Pharmaceuticals and Proteus Digital Health — send a message from the pill’s sensor to a wearable patch that links to a mobile app.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “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.”

Otsuka said that the pairing of the sensor with the antipsychotic Ability was designed to allow patients with schizophrenia, bipolar I disorder or major depressive disorder to better track their daily medication intake and share that with their care team — which they can control through the linked app. The company said that the product would see an initial limited rollout with a select number of health plans and providers, who will select certain patients, on whose experiences Otsuka said I would base future enhancements.

“This approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies,” Otsuka president and representative director Tatsuo Higuchi said. “We remain committed to making a difference for individual patients and their care team by helping address the challenge of objectively measuring medication ingestion. 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 sensor is made up of ingredients “found in food,” the company said, noting that it was the size of a grain of sand and activates when the sensor material comes into contact with stomach fluid. The MyCite patch records the date and time of the ingestion, as well as some physiological data. The FDA noted that product is not for use in emergency or real-time situations, as detection could be delayed or not occur. The agency also noted that the product has not shown an ability to improve patient compliance with a treatment regimen.

“The time is right for the category of digital medicines to be available to appropriate patients with serious mental illness,” Proteus Digital health president and CEO Andrew Thompson said.  “Consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smart phones, as they go about their daily lives. With this FDA approval, Otsuka can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way.”