On November 13, 2017, the United States Food and Drug Administration (USFDA) approved the first ever drug in  the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible  sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment  of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as  an add-on treatment for depression in adults1.

The system works by sending a message from the pill's sensor to a wearable patch. The patch transmits the  information to a mobile application so that patients can track the ingestion of the medication on their smart  phone. Patients can also permit their caregivers and physician to access the information through a web-based  portal.

Schizophrenia is a chronic, severe and disabling brain disorder. Symptoms of schizophrenia include hearing  voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or  withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual  shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar  disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness,  racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product comprising of Otsuka's  oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. This IEM sensor is the size of a  grain of sand, and is made up of ingredients found in food. The IEM sensor gets activated when it comes in  contact with stomach fluid and communicates to a wearable sensor, called the MYCITE Patch. The IEM sensor is  then digested and eliminated from the body.

The ABILIFY MYCITE System includes: ABILIFY MYCITE, the MYCITE® Patch (wearable sensor); the MYCITE APP (a  smartphone application); and web-based portals for healthcare providers and caregivers. The system records  medication ingestion and communicates it to the patient and healthcare provider. In addition, it can collect data  on activity levels, as well as self-reported rest and mood which, with patient consent, can be shared with the  healthcare provider and selected members of the family and care team. The system provides an objective  summary of drug ingestion over time, to help enhance collaboration with healthcare providers who treat patients  with certain serious mental illnesses2.

Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite  was first permitted for marketing by the FDA in 2012. The FDA granted the approval of Abilify MyCite to Otsuka  Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.

Conclusion:

The approval of ABILIFY MYCITE, the first digital medicine system, provides an innovative way to treat individuals  with serious mental illness, and also provides valuable information about patient medication ingestion patterns,  that could help physicians in better illness management and provide more personalized treatment plan to  individual patients.

Footnotes

1 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm

2 https://www.otsuka-us.com/discover/articles-1075

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