FDA Approves First U.S. Drug with Digital Ingestion Tracking

Otsuka Pharmaceutical’s Abilify MyCite for schizophrenia includes an ingestible sensor embedded in the pill that sends a message to a patch worn by the patient, which transmits information to a mobile app, permitting smartphone tracking and communication.

Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health announced that the U.S. Food and Drug Administration (FDA) granted the first approval of digital medicine system, Abilify MyCite® (aripiprazole tablets with sensor), a drug-device combination product comprised of Otsuka’s oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor.

Otsuka explains that the Abilify MyCite system includes Abilify MyCite, the MyCite® Patch (a wearable sensor, developed by Proteus); the MyCite® APP, a smartphone application, used with a compatible smartphone to display information for the patient; and web-based portals for healthcare providers and caregivers that display a summary of aripiprazole ingestion over time. Only functions of the app related to tracking drug ingestion have been approved by the FDA.

FDA notes, “The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone. Patients can also permit their caregivers and physician to access the information through a web-based portal.”

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” says Mitchell Mathis, M.D., 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.”

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 company notes that Abilify MyCite is intended to track drug ingestion, pointing out, “The ability of Abilify MyCite to improve patient compliance or modify aripiprazole dosage has not been established.”

“The approval of Abilify, the first digital medicine system, means that for the first time in my years of experience as a psychiatrist, there is an innovative way to provide individuals with serious mental illness, and selected members of their families and care teams, with information on objective medication taking patterns to help inform the patient’s illness management and personalized treatment plan. This information allows the opportunity for an open dialogue with the patient,” says John Kane, MD, SVP, Behavioral Health Services, Northwell Health and Chair, Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. “Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug.”

Otsuka explains, “The system has been designed for the individual with serious mental illness to allow them to record their daily medication intake and have a more informed dialogue with their healthcare team. The system is intended to integrate into individuals’ lives, and individuals indicate through the app which member(s) of their care team can access information about their medication ingestion, activity, and self-reported mood and rest. For physicians, this information, assessed in collaboration with the individual, helps facilitate a more open dialogue. The hope is to provide additional clarity to better inform decision-making for physicians and their patients. Patients can discontinue sharing some information from the system, or opt out of the program altogether, at any time.”

Tatsuo Higuchi, President and Representative Director of Otsuka Pharmaceutical Co., Ltd., remarks, “This approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies. 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.”

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. Consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smartphones, 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.”

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