• linkedin
  • Increase Font
  • Sharebar

    First Drug with an Ingestible Sensor Approved


    The FDA has approved Abilify MyCite (Otsuka), tablets of aripiprazole embedded with an ingestible sensor that can record that the medication was taken. The tablet with sensor is an attempt to help increase adherence to medication regimens.

    Aripiprazole is used to treat schizophrenia, as an acute treatment for manic and mixed episodes associated with bipolar I disorder, and as an add-on treatment for depression in adults. Patients with these mental health conditions can struggle with taking their medications consistently and can have trouble keeping track of whether they have taken them.

    The sensor works by sending a signal to a patch worn by the patient. The patch then sends information to a mobile app on a smart phone, which allows the patient to monitor whether they have taken their medication. If the patient chooses, this information can be shared with caregivers and health-care providers.

    “Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, MD, Director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in a statement. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

    However, the FDA has a warning in its announcement of Abilify MyCite’s approval: “It is important to note that Abilify MyCite’s prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown.”

    The generic name for Abilify MyCite is “aripiprazole tablets with sensor,” and it is a collaboration between pharmaceutical company Otsuka and Proteus Digital Health. The product had been rejected by the FDA in early 2016.

    Valerie DeBenedette
    Valerie DeBenedette is Managing Editor of Drug Topics.


    You must be signed in to leave a comment. Registering is fast and free!

    All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

    • No comments available
    10 Old Remedies You Wont Find on Pharmacy Shelves Today
    10 Old Remedies You Wont Find on ...

    Not too long ago, it seemed like anything could end up in a pharmacy—with disastrous (or sometimes just humorous) results.

    2018 Novel Drug Approvals: The First ...
    Five Tips for Surviving a 12-Hour ...
    The Top 5 Pharmacist Movies of All Time