FDA approves first pill with digital tracking system
[Maryland, US] The US Food and Drug Administration (FDA) has now approved the first pill with an incorporated digital tracking system that records medication ingestion.
Called Abilify MyCite, the tablets include an ingestible sensor that records a message which is then transmitted to a wearable patch and to an app that patients can access on their smartphones.
The data can also be seen by physicians and carers through a web-based portal if patients give their consent.
The pill, first approved by the FDA in 2002 to treat schizophrenia, is developed by Otsuka Pharmaceutical Co. and the sensor and patch by Proteus Digital Health.
The new ‘drug-device’ product will be made available for schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and as add-on treatment for depression in adults.
Mitchel Mathis, Psychiatry Products Division Director at the DA Centre for Drug Evaluation and Research, said the FDA supports the ‘development and use of new technology’ in prescription drugs.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” he added.
However, Abilify MyCite should not be used to track ingestion in real-time or in case of an emergency as it can take from 30 minutes to two hours for the information to be detected.