FDA approves Abilify MyCite, a drug that digitally tracks when it’s ingested

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Takeaway

  • The FDA has approved the first-ever pill that digitally tracks when a patient takes it.
  • The pill, aripiprazole (Abilify MyCite), has an embedded sensor (Proteus Digital Health) that sends a message to a skin patch upon ingestion; the patch relays the information to the user’s smartphone.
  • Patients can give clinicians or caregivers access to the information via a web portal.

Why this matters

  • Remembering to take medications can be difficult for any patient.
  • Patients with the conditions that this drug treats, including schizophrenia and bipolar disorder, can struggle with executive function, including remembering to take medications or when they last took them. 

Highlights

  • Prescribing information for this drug notes that effects on drug adherence have yet to be shown. 
  • The FDA allowed marketing of the sensor in 2012 but delayed approval of Abilify MyCite in 2016, calling for more information.
  • Aripiprazole comes with a boxed warning that elderly patients with dementia-related psychosis are at increased mortality risk with antipsychotic drug treatment, and the sensor-equipped version is not approved for patients with dementia-related psychosis.
  • The warning also notes increased risk for children, adolescents, and young adults for suicidal thinking and behavior.
  • Abilify MyCite safety and effectiveness are not established in the pediatric population.