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Abilify MyCite FDA Approval History

FDA Approved: Yes (First approved November 13, 2017)
Brand name: Abilify MyCite
Generic name: aripiprazole
Dosage form: Tablets with Sensor
Company: Otsuka Pharmaceutical Co., Ltd
Treatment for: Schizophrenia, Bipolar Disorder, Depression

Abilify MyCite (aripiprazole) is a tablet formulation of the approved atypical antipsychotic aripiprazole embedded with an ingestible Proteus® sensor that communicates with a wearable sensor patch and a medical software application to measure adherence in the treatment of adults with schizophrenia, bipolar I disorder, and major depressive disorder.

How does Abilify MyCite work?

  1. The tablet is embedded at the point of manufacture with an Ingestible Event Marker (IEM), which is a tiny sensor about the same size as a grain of sand.
  2. The IEM sensor is activated when it comes into contact with the stomach fluid. The IEM sensor then communicates the date and time of the ingestion of the tablet to the MyCite Patch, a wearable sensor applied to the the left hand side of the body above the lower edge of the rib cage. The patch remains in place up to seven days, after which it is replaced.
  3. The information collected in the Patch is communicated to the MyCite App, a smartphone application downloaded on a compatible mobile device. The app allows the patient to review their data with their doctor.
  4. The patient can choose through the app which members of their care team and family can access their information.
  5. Secure web-based dashboards give the healthcare provider access to medication ingestion patterns over time.

Development timeline for Abilify MyCite

Nov 13, 2017Approval FDA Approves Abilify MyCite (aripiprazole) Pill with Sensor to Digitally Track if Patients Have Ingested Their Medication
Apr 26, 2016FDA Issues Complete Response Letter for Digital Medicine New Drug Application
Sep 10, 2015U.S. FDA Accepts First Digital Medicine New Drug Application for Otsuka and Proteus Digital Health

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.