The first digital medicine that tracks its own ingestion

The ABILIFY MYCITE System includes: ABILIFY MYCITE, the MYCITE Patch (a wearable sensor, developed by Proteus); the MYCITE APP, a smartphone app, 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. 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. ABILIFY MYCITE is intended to track drug ingestion.

The ability of ABILIFY MYCITE to improve patient compliance or modify aripiprazole dosage has not been established. The use of ABILIFY MYCITE to track drug ingestion in “real-time” or during an emergency is not recommended because detection may be delayed or not occur.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death (1.6 to 1.7 times) compared to placebo-treated patients. ABILIFY MYCITE is not approved for the treatment of patients with dementia-related psychosis.

Antidepressants increased the risk of suicidal thoughts and behaviour in children, adolescents, and young adults. Those on antidepressant therapy should be monitored closely for worsening, and for emergence of suicidal thoughts and behaviours.

“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 personalised treatment plan".

"This information allows the opportunity for an open dialogue with the patient,” said John Kane, MD, SVP, behavioural 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.” A person living with serious mental illness, in collaboration with his or her physician, decides whether this new digital medicine system may help them manage their approach to treatment.

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.

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.

Otsuka’s approach for this first-of-its-kind treatment is novel for a pharmaceutical company. As such, the launch of the ABILIFY MYCITE system will be conducted in close collaboration with only a select number of health plans and providers, who will identify a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder who may benefit from this new digital medicine system.

This limited rollout is purposeful, as having fewer people using the system initially means their prescribers, health plans, and Otsuka can focus on learning from these patients’ experiences.

Through ongoing feedback from those using the system every day, Otsuka will further enhance the experience for all prospective users of the ABILIFY MYCITE system. This initial limited rollout will be a crucial step in determining Otsuka’s broader go-to-market plan.

Tatsuo Higuchi, president and representative director of Otsuka Pharmaceutical Co., Ltd., remarked, “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 chief executive officer of Proteus Digital Health said, “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.”