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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 adults.
According to an FDA press release, 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 smartphone. Patients can also permit their caregivers and physician to access the information through a web-based portal.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in the FDA press release. “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.”
The FDA noted in its release that the ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in “real-time” or during an emergency because detection may be delayed or may not occur, the agency added.
The “digital health feedback system” (DHFS) has attracted the attention of clinician researchers interested in novel ways to improve medication adherence among patients with schizophrenia and bipolar disorder. In 2010, John Kane, M.D., and colleagues at Zucker Hillside Hospital and Massachusetts General Hospital partnered with Proteus Digital Health Inc.—the manufacturer of the DHFS technology—to characterize the feasibility and safety of the system in patients with bipolar disorder and schizophrenia. A principle concern at the outset was whether patients who may have paranoid or persecutory delusions would be amenable to using a device allowing others to monitor their behavior.
In a paper published in the Journal of Clinical Psychiatry (June 2013), Kane and colleagues found that of the 27 patients with schizophrenia or bipolar disorder who completed the study, none experienced a worsening of psychosis attributable to use of the DHFS, 19 found the DHFS concept easy to understand, and 24 said they believed the technology could be useful to them. (For the purposes of the study, the pill with the embedded DHFS was not pharmacologically active.)
For related information, see the Psychiatric News article “Technologies Promise to Aid Medication Adherence, but Effectiveness Varies.”