UPDATED November 14, 2017 // The US Food and Drug Administration (FDA) has approved aripiprazole pills that have an ingestible sensor embedded in them that digitally records whether and when the medication is taken. Abilify MyCite (Otsuka Pharmaceutical Co/Proteus Digital Health) is the first digital medicine system to be cleared by the FDA.

The product is approved for the treatment of schizophrenia, the acute treatment of manic episodes, the treatment of mixed episodes associated with bipolar I disorder, and for use as adjunctive treatment for major depressive disorder in adults.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," Mitchell Mathis, MD, director, Division of Psychiatry Products, Center for Drug Evaluation and Research, FDA, said in a news release. "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."

The system works by sending a message from the pill's sensor to a wearable patch, which transmits the information to a mobile application, allowing patients to record their daily medication intake on their smartphone. Patients can allow their healthcare provider to access the information through a Web-based dashboard. The patch detects and records the date and time of the ingestion of the tablet as well as certain physiologic data, such as activity level.

The pill's sensor is the size of a grain of sand and is made up of ingredients found in food. The sensor becomes activated when in contact with stomach fluid and is then digested and eliminated from the body.

"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," John Kane, MD, senior vice president, Behavioral Health Services, Northwell Health, Glen Oaks, New York, said in a news release from Otsuka and Proteus Digital Health.

"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," said Dr Kane.

Big Brother?

In an interview with Medscape Medical News, Jeffrey Lieberman, MD, professor and chair of psychiatry at Columbia University and psychiatrist-in-chief at the New York–Presbyterian Hospital, New York City, said he would "categorically say this innovation of marrying this technology to pharmacologic therapeutics is good and positive. But there are a lot of questions in terms of what added value it will provide to patients and healthcare providers and whether it's worth whatever the incremental cost may be. That will depend on what the evidence ultimately shows in terms of improving adherence and reducing the consequences of treatment nonadherence. But we don't know how effective in that regard this will be because those studies have not been done."

It also remains to be seen whether patients with schizophrenia accept digital Abilify.

"When you think the treatment is indicated for people who have psychotic symptoms, like paranoid delusions, questions may be introduced that it is intrusive or that it sounds kind of like overbearing government, Big Brother intrusion into my personal autonomy," said Dr Lieberman.

Reached for comment, Michael Birnbaum, MD, director, Early Treatment Program (for psychosis), Lenox Hill Hospital, New York City, told Medscape Medical News that the "continual adoption of new and innovative technological tools is ubiquitous. This holds true for individuals with schizophrenia as well. Technology will revolutionize behavioral healthcare, and this advancement is simply the beginning of the digital transformation.

"While some may initially feel wary, for many, these resources provide an opportunity to passively extract digital data which can be critical to improving outcomes. On a personal level, a digital ingestion tracking system can help remind people with schizophrenia if they forgot to take medications. This is a step forward in obtaining more focused and precise information regarding medication adherence and can help make personalized informed decisions, which is a defining feature of precision medicine," Dr Birnbaum added.

Limited Rollout

The ability of aripiprazole tablets with imbedded sensor to improve patient compliance or modify aripiprazole dosage has not been established. The use of the product to track drug ingestion in real time or during an emergency is not recommended because detection may be delayed or may not occur. It can take 30 minutes to 2 hours to detect ingestion of the tablet. Sometimes the system might not detect that the medication was taken.

According to the manufacturer, the launch of the Abilify MyCite system will be conducted in close collaboration with 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," the manufacturer said.

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