FDA on Monday approved the first pill with a sensor that can track if patients have swallowed it-a technological advance that could be a game-changer for treating mental health disorders and chronic diseases like diabetes where medication adherence has always been a challenge.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a Monday statement. "The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how this technology might benefit patients and prescribers". Also, patients can give their physicians or caregiver's permission to access this data through a web-based portal.
But until now, the FDA had not approved a sensor-pill combination.
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"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 FDA said in the November 13 statement.
The marketing of digital medicines stresses the need to improve patient medication adherence as well as helping healthcare providers better tailor treatment to a patients needs, but the announcement drew concerns in the media of Big Brother watching, particularly since approval was granted for a medicine used to treat mental health disorders.
The system in the drug offers an objective way to measure whether patients have taken their pills on schedule, which opens up new ways to monitor treatment compliance that can be applied in other therapeutic cases.
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Always forget if you've taken your medication? The system is meant to integrate into individuals' lives, and individuals indicate through the app which member (s) of their care team can access information about their medication ingestion, activity, and self-reported mood and rest. "Patients can discontinue sharing some information from the system, or opt out of the program altogether, at any time".
Abilify MyCite combines oral aripiprazole tablets from Otsuka Pharmaceuticals with an Ingestible Event Marker sensor to track if the medication has been taken.
Abilify MyCite is not approved for treating patients with dementia-related psychosis. By allowing physicians to track a patient's use, Nath said he hopes to avert "dramatic and immediate health-care crises, such as for schizophrenia patients where missing medicines can result in a psychotic break which will land them in an ER". Consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smartphones, as they go about their daily lives.
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