FDA approves sensor-embedded drug

By Daphne Allen in Regulatory on November 21, 2017

FDA has approved the new drug application for Abilify MyCite (aripiprazole tablets with sensor) to track drug ingestion.

Abilify MyCite was approved for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, maintenance treatment of bipolar I disorder, and adjunctive treatment of major depressive disorder.

Otsuka Pharmaceutical Co. Ltd. and Proteus Digital Health worked on the project. Calling Abilify MyCite “the first FDA-approved digital medicine system,” the companies report in a a press release that the aripiprazole tablet is embedded with an ingestible event marker (IEM) sensor that is about the size of a grain of sand.

Consisting of ingredients found in food, the sensor activates when in contact with stomach fluid and communicates to the wearable MyCite Patch. The sensor is then digested and eliminated from the body, the companies report in the release.

The MyCite App tracks drug ingestion, and Web-based portals for healthcare providers and caregivers allow them to view a summary of aripiprazole ingestion over time.

John Kane, MD, SVP, Behavioral Health Services, Northwell Health and Chair, Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, shared his perspective. “The approval of Abilify MyCite, 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,” he stated in the release. “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."

Abilify MyCite will be launched in what is described as a “limited rollout.” Tatsuo Higuchi, president and representative director of Otsuka Pharmaceutical, stated that “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 chief executive officer of Proteus Digital Health added: “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 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.”

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