FDA has approved the first digital pill with an embedded sensor to track if patients are taking their medication properly. Abilify MyCite is the only version currently approved with the digital tracking system.
The approval marks a significant advance in the growing field of digital devices designed to monitor medicine-taking and to address the expensive, longstanding problem that millions of patients do not take drugs as prescribed.
The pill, Abilify MyCite, an anti-psychotic medication with a sensor embedded inside, can now be used for 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.
The ingestible sensor is activated by gastric juices and sends a unique, identifying signal to a wearable patch. That patch automatically logs the date and time of the signal (as well as other basic health information) and can transmit that information via Bluetooth to a paired mobile device.
The drug Abilify MyCite was developed by Otsuka Pharmaceutical Co., Ltd. The drug Abilify was first approved by the FDA in 2002 to treat schizophrenia and the ingestible sensor, made by Proteus Digital health, was approved for marketing in 2012.
The FDA said that being able to track ingestion of medicines prescribed for mental illness may be useful “for some patients,” although the ability of the digital pill to improve patient compliance had not been proved.
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 statement said. Abilify MyCite is expected to hit the market next year, but the price has not yet been set.
Abilify MyCite is not approved to treat patients with dementia-related psychosis and contains a boxed warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.