FDA Approves Antipsychotic Agent With Sensor to Track Ingestion

The system works by sending a message from the pill's sensor to a wearable patch
The system works by sending a message from the pill's sensor to a wearable patch

The Food and Drug Administration (FDA) has approved Abilify MyCite (aripiprazole tablets with sensor), the first digital medicine system that tracks if patients have ingested their medication. 

Abilify MyCite is indicated for the:

  • Treatment of schizophrenia, 
  • Bipolar I disorder (acute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate; and maintenance treatment as monotherapy, and as adjunct to lithium or valproate) 
  • Adjunctive treatment of major depressive disorder

Abilify MyCite consists of the atypical antipsychotic Abilify (aripiprazole; Otsuka) tablets embedded with an Ingestible Event Marker (IEM) sensor. The system also includes the MyCite Patch, a wearable sensor (Proteus), and the MyCite App intended for use with a compatible smartphone to display information. The IEM sensor is made up of ingredients found in food and is the size of a grain of sand. When it comes in contact with stomach fluid, the sensor activates and sends signals to the MyCite Patch that documents the date and time of tablet ingestion.

Web-based dashboards are available for healthcare providers and caregivers to monitor the patient's aripiprazole ingestion over time. The system also obtains data on activity level, and self-reported rest and mood that can be shared with caregivers and family as well as healthcare providers. Patients can stop sharing data or opt out of the program at any time.

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"Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug," said John Kane, MD, SVP, Behavioral Health Services, Northwell Health and Chair, Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell.

Abilify MyCite is designed to track drug ingestion; it is not recommended for tracking in "real-time" or emergency situations as it may take 30 to 120 minutes to detect tablet ingestion. Prior to initial patient use, clinicians should facilitate use of the combination product and its components (patch, app, portal) to ensure that the patient is capable and willing to use smartphones and apps.

Abilify MyCite will be available as 2mg, 5mg, 10mg, 15mg, 20mg, and 30mg strength tablets with sensor in 30-count bottles co-packaged with 7 patches. The product is anticipated to launch in 2018.

For more information call (800) 438-9927 or visit AbilifyMyCite.com.

Courtesy of Otsuka Pharmaceutical and Proteus Digital Health.