In a world first, the US Food and Drug Administration (FDA) has approved a psychiatric drug embedded with an ingestible sensor that can remotely track when the medication is taken. Otsuka Pharmaceutical’s Abilify MyCite is the new high-tech version of the company’s popular antipsychotic drug which has been approved to treat schizophrenia, bipolar I disorder and depression.
The sensor-containing drug is paired with a wearable external patch which detects when the medication has been ingested. The patch then transmits this data to a smartphone app to allow patients, as well as approved caregivers and physicians, to monitor medication adherence.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Dr. 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.”
While the sensor technology – developed by Proteus Digital Health – was certainly designed to help improve patient adherence to medications, the FDA points out that Abilify MyCite has not been demonstrated to improve patient compliance.
“The approval of Abilify MyCite, the first digital medicine system, means that for the first time in my years of experience as a psychiatrist, there is an innovative way to provide individuals with serious mental illness, and selected members of their families and care teams, with information on objective medication taking patterns to help inform the patient’s illness management and personalized treatment plan. This information allows the opportunity for an open dialogue with the patient,” said Dr. John Kane, Behavioral Health Services, Northwell Health and Chair, Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. “Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug.”
Abilify was originally approved by the FDA in 2002. Since then, the antipsychotic has been a blockbuster drug for Otsuka, bringing in around 9 billion in sales in 2016. The FDA recommends that physicians discuss whether the drug-device combination product is appropriate for the patient before starting treatment.