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Abilify MyCite first FDA-approved smart health connected pill , smart health device review

April 08, 2020

Abilify MyCite: first smart health connected pill authorized by the FDA e-health Date of last modification: 22 Apr 2019

Abilify MyCite, the first smart health connected Pill authorized in the United States

In the market for smart health connected smart health devices, innovations are accelerating and the authorities are starting to get involved. In the United States, the Food and Drug Administration authorized the marketing of Abilify MyCite: the first smart health connected pill. The FDA is the equivalent of the European Medicines Agency which, with Brexit, will set up in Amsterdam.

The digital stamp allows to generate data like the when the pill was taken and how much you took. A complementary patch, stuck on the abdomen, also records activity level, sleep patterns, physical activity and heart rate.

This innovation is the fruit of collaboration between the Japanese pharmaceutical laboratory Otsuka (drug) and the digital medicine department Proteus Digital Health (sensor and patch). Abilify MyCite is a pill to treat schizophrenia and bipolar disorder. It is also used in adjunct treatment for cases of depressions.

The pill is one way of tackling the problem of patients who are not taking their medication correctly. IQVIA believes that the inappropriate and unnecessary use of drugs has cost more than $ 200 billion in 2012. The approval also opens the door to the digitization of pills that are used for conditions other than mental health.

  1. The sensor Proteus Digital is coated in Otsuka aripiprazole (atypical antipsychotic) tablets. The grain-sized "MyCite" sensor is made of silicon, copper and magnesium.

  2. The sensor components provide an electrical signal when it comes into contact with stomach acid. This allows you to detect and record the date and time the tablet was taken, as well as certain physiological data such as activity level.The activation time is unfortunately not instant. So the FDA specifies that the delay can vary from 30 min to 2 hours. Sometimes the system may not detect that the medicine has been taken. However, if the application does not indicate that the tablet has been taken, the patient should not take a new dose.

  3. The information collected in the Patch is transmitted by Bluetooth to theMyCite smartphone app, on a compatible mobile phone. The MyCite app allows the patient to consult their data on medication ingestion with their doctor. Activity level can also be recorded by the app, as well as sleep quality.Disadvantage, the patch must be replaced every seven days.

  4. The patient, via the mobile phone application, can give or revoke the sharing of information with their healthcare team or members of their family.

  5. To access shared patient information, authorized people access a web platform dedicated to secure dashboards allowing to follow the evolution of data over time.

Only the app’s features related to monitoring medication intake have been approved by the FDA.

Abilify MyCite pricing and support

Like any drug, the Abilify pill required years of research and testing funded by a $ 400 million fund. Result: more than 300 patents filed.

Otsuka has not yet specified the selling price of Abilify MyCite tablets. They should be available in 2018, without further details on the dedicated mini site (reserved for American health professionals).

The Wall Street Journal reports that the laboratory will negotiate with American insurers to allow the management of its smart health connected pills.

Beginning of controversy linked to each innovation

Experts have, however, expressed concerns about what the pill could mean for privacy. Some fear that monitoring the pills is a step towards punishing patients who do not comply. Ameet Sarpatwari, a professor of medicine at the Harvard Medical School told the New York Times that " the digital pill has the potential to improve public health. But if used improperly, it could generate more distrust than confidence. "

Other smart health connected pills expected

The Wall Street Journal reports that the FDA is expecting a series of applications for approval for other digital pills. An FDA spokesperson said it plans to hire more staff with a "deep understanding" of medical device software development. An example to follow for our social security and ministry of health.

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