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Schizophrenia Drug Abilify Now FDA-Approved for Digital Tracker You Swallow

Biodegradable “Smart Pill” Tech Around Since early 2010s; Market Booming

 

A pill that can signal a computer that you’ve taken your medicine sounds farfetched. 

 

But “ingestibles,” or tiny electronic tracking devices inside pills that you swallow, made headlines again on Nov. 13, when the FDA approved the MyCite system for use with Abilify.

 

Abilify is an existing drug made by Japan’s Otsuka Pharmaceutical.  It was FDA-approved in 2002 to treat schizophrenia, a mental-health disorder affecting nearly one percent of Americans.

 

MyCite is made by California-based Proteus Digital Health.  MyCite consists of an ingestible sensor, a skin patch and a smartphone app.

 

The MyCite sensor is one square millimeter, the size of a sand grain.  It’s made of digestible metals copper and magnesium.  It’s contained in the Abilify pill.

 

The small MyCite skin patch contains a battery and a signal receiver/transmitter.  It is worn on the patient’s torso.

 

The MyCite smartphone app helps patients track their daily pill usage and communicate with their doctors.

 

The sensor in the Abilify pill is activated by electrolytes in the digestive system.  It transmits a signal to the patch.  The patch sends a signal to the smartphone app.  The app then sends a signal to the doctor.

 

With the FDA approval, Otsuka and Proteus hope that Abilify MyCite will help more schizophrenia patients stay on top of their vital daily medication.

 

However, both companies note that the system is not perfect and pill detection may be delayed or may not occur—meaning that Abilify MyCite should not be used to track real-time pill ingestion.

 

New use, new(-ish) tech

Smart pill technology has actually been around since the early 2010s in several FDA-approved mainstream usages.

 

The concept of Abilify MyCite and other smart pill systems is to help adults remember if they’ve taken their daily medications—or help parents or doctors know if children have not taken their medications (even if they insist that they have!).

 

Technological confirmation that medication is being taken is important: It helps keep doctors from concluding that “taken” medication is not working, preventing the changing of dosages or medications prescribed.

 

The Proteus Discover sensor patch was initially approved by the FDA in 2010.  The ingestible sensor pill won FDA clearance in July of 2012.

 

In January of 2016, the California-based Barton health system began using Proteus Discover for hypertension patients—become the first U.S. user of that system.

 

Proteus Discover has been in use at the Children’s Health hospital system in Dallas, Texas since February of this year.  Doctors there use ingestible trackers to remotely monitor medication adherence in a group of teen patients who’ve had organ transplants.  Children’s Health was also reported to be working with Proteus to expand the number of medications that can be co-encapsulated with the sensor.

 

In recent years, MIT researchers essentially created a tiny ingestible stethoscope.  The silicone capsule, roughly the size of a multivitamin, holds a tiny microphone, data processor and transmitter that collects and broadcasts heart and lung sounds from inside the body.

 

And Scripps Health is currently developing tiny sensors that travel the bloodstream to send messages to a smartphone, alerting the user of signs of infection, an impending heart attack or other cardiovascular issues.

 

Booming market

Ingestible sensing capsules are fast emerging as a critical technology that has the ability to greatly impact health, nutrition, and clinical areas.

 

For example, they can reveal the state of gut health and disorders as well as the impact of food, medical supplements, and environmental changes on the gastrointestinal tract.

 

Most ingestible sensors are currently used to measure inner body or organ temperatures, pressures and pH levels.  Other smart pills, equipped with tiny cameras, actually take photos of internal organs.

 

Most importantly, the ingestible devices are noninvasive.

 

And with widespread access to smart phones connected to the Internet, the data produced by the technology can be readily seen and reviewed online, and accessed by both users and physicians.

 

The ingestible sensor market is growing due to the need for real-time patient monitoring, medication adherence, and an increasing number of cases of chronic diseases, as well as improved accuracy in invasive diagnosis tests.

 

According to one recent report on ingestible sensors earlier this year, the market is expected to grow from 2015’s $198 million to over $678 million by 2022.  (Another report from a few years ago actually pegged the market’s 2017 figures at over $900 million.)