FDA Approves Pill that Tracks Ingestion


Many people are familiar with that feeling of uncertainty when you can’t remember if you took your medication or not. Sometimes, missing a pill isn’t such a big deal. Other times, it can have serious consequences. To deal with these issues, Proteus Digital Health and Otsuka Pharmaceutical have obtained FDA approval for the world’s first digital pill that can be tracked.

Named Abilify MyCite, the pill contains aripiprazole for the treatment of adults with schizophrenia, acute manic and mixed episodes, bipolar I disorder, and major depressive disorder, as well as a tiny embedded sensor. The sensor is activated by stomach juices after the pill is swallowed and dissolved, allowing it to transmit data to a patch worn by the patient, and from there to a smart phone or tablet to notify the patients caretakers or doctor that the pill has been ingested. The sensor is then passed through the gastral intestinal (GI) system naturally.

Despite the benefits offered by this new technology, it should be noted that Abilify MyCite’s labeling states that it should not be used for “real-time” ingestion tracking or during an emergency because detection may be delayed. Some patients may also experience irritation at the site of the patch application, or other side effects.

Abilify MyCite must be dispensed with a patient Medication Guide that outlines the drug’s uses and risks. Before the patient uses the pill for the first time, their health care professional should assist with use of the drug, patch, and app to ensure the patient is capable and willing to use the system.

Abilify was first approved by the FDA to treat schizophrenia in 2002. The ingestible sensor used in Abilify MyCite was first permitted by the FDA for marketing in 2012. Abilify was chosen to be paired with the sensor as patients who suffer from the conditions listed above often have medication compliance issues. It is hoped that the new tracking system will help alleviate these problems and promote optimal therapy and rehabilitation.

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