FDA approves first 'digital' pill

November 14, 2017 //By Rich Pell
The U.S. Food and Drug Administration (Silver Spring, MD) has approved a pill that includes a sensor that digitally tracks if patients have ingested it.

The digital medicine system - called Abilify MyCite - contains a schizophrenia drug developed by Otsuka Pharmaceutical Co., Ltd. (Tokyo, Japan) and an "ingestible event marker" sensor designed to help doctors digitally monitor if and when patients have taken their medication. The pill is designed to address the issue of patient noncompliance to medication, which is estimated to cost about $100 billion a year as a result of patients becoming sicker and requiring additional treatment or hospitalization.

The pill's sensor reportedly contains safe ingredients commonly found in foods, such as copper, magnesium, and silicon. When the sensor comes in contact with stomach fluid, it generates an electrical signal.

After 30 minutes to two hours, that signal is then detected by a wearable patch worn by the patient, which then transmits the date and time, and patient activity level via Bluetooth to a smartphone or mobile device, enabling patients to track the process. The information can also be accessed through a web-based portal by caregivers or physicians who have been allowed permission by the patient.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," says Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "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 roll-out of the Abilify MyCite system will be done in phases, initially being limited to a select number of health plans and providers. They will identify a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder who they determine may benefit from the new digital medicine system.

Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor technology and patch are made by Proteus Digital Health (Redwood City, CA).