World's First Digital Drug: FDA Approves Pill That Can Track If Patients Swallow It


The U.S. Food and Drug Administration (FDA) approves Otsuka Pharmaceutical Co., Ltd.'s Abilify MyCite, the world's first digital drug that tracks whether patients have swallowed the drug or not.

The Sensor Technology

Abilify MyCite is an antipsychotic pill that uses a sensor-based technology to help patients, as well as doctors, keep track of ingestion by sending a message to a wearable sensor patch where the information is then forwarded to a smartphone app.

The sensor activates when the pill gets wet in the patient's stomach. It's as tiny as a grain of sugar and uses no battery and no antenna.

Proteus Digital Health, a California-based company, is responsible for developing the ingestible sensor. The FDA first approved the technology back in 2012.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," said 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."

Abilify MyCite

The FDA approved Abilify MyCite for treating a number of mental disorders including schizophrenia, manic and mixed episodes associated with bipolar 1 disorder. The FDA first approved the medicine back in 2002.

The medicine, however, is not used to treat patients who suffer from psychosis related to dementia. The medicine contains a "boxed warning" that cautions health care professionals about using the drug for patients who have dementia-related psychosis.

Proteus Digital Health

In addition to Japan's Otsuka, Proteus has received a number of investments from other big companies such as Novartis AG, Medtronic Inc, and Jude Medical Inc.


Schizophrenia is a chronic and severe mental disorder that affects how people think, feel, and behave. A person who suffers from this mental disorder appears to be out of touch with reality. Symptoms of Schizophrenia include hallucinations, delusions, thought disorders, and movement disorders.

According to the FDA, around 1 percent of American adults have this illness.

Bipolar I Disorder

Bipolar 1 disorder, on the other hand, is a brain disorder that causes unusual shifts in activity, energy, and mood. A person who suffers from this disorder may experience manic episodes that can last up to 7 days.

According to the National Institue of Mental Health (NIMH), the brain disorder affects nearly 5.7 million American adults, which is about 2.6 percent of the population.

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