US FDA Approves First Pill with Digital Tracking Device
The pill named Abilify MyCite is the first aripiprazole tablet with sensor, which is approved by US Food and Drug Administration (FDA) on November 15, 2017.
Abilify MyCite is designed for patients suffering from schizophrenia, bipolar disorder, and depression. Pill with sensor can assist in giving alert to doctors and caregivers to track patient medication as scheduled. After patient ingests the pill, sensor inside the pill gets activated when it comes in contact with stomach fluids. Activated sensor sends the message to wearable patch. The patch transmits the recorded information to a mobile app, so that a doctor and up to four caregivers, friends or family members can see the information through a web-based portal.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research. 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 approved Abilify in 2002 to treat schizophrenia, which affects about one percent of the US population. The ingestible sensor used in Abilify MyCite was first approved in the market by the FDA in 2012. Although the sensor can alert caregivers, the manufacturers of Abilify, Japan-based Otsuka Pharmaceutical, said it is unclear whether the tracking device will actually help improve patients’ ability to take their medication daily as prescribed.
The sensor technology and patch are made by Proteus Digital Health and are approved for use with existing medications in the U.S and Europe. Some experts raised questions about the choice of Abilify as the drug with sensor. “Patients with a tendency towards paranoia may feel a bit uncomfortable being monitored in this fashion. Patients with bipolar disorder and schizophrenia are very often non-compliant with their medication and the result is almost always a relapse.” said Seth Mandel, chairman of psychiatry at Northwell Health’s Huntington Hospital in New York.
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