The pill, Abilify MyCite, is prescribed for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and as an add-on treatment for depression in adults.
This patch sends the ingestion data to a smartphone app so patients are able closely to track the ingestion of medication. Patients can allow caregivers and physicians to access the information through an online portal.
"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", Mitchell Mathis added.
Abilify MyCite may raise some privacy concerns, but patients must also agree to the pill and sign a release prior to taking it. Patients can also opt out of the program at any time. "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".
Before this Otsuka Pharmaceutical Co Ltd's established drug Abilify, equipped with sensors was given approval in 2012.
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. However, whether or not the digital pill will actually improve patient compliance with their prescribed medications has not yet been proven, and will certainly be of interest as the first of the sensor-equipped pills roll out. The patch runs on a tiny battery, while the sensor itself-about the size of a grain of sand and made of ingredients found in food-is powered by fluids in the stomach. And digital systems could spare time and resources by replacing current practices of having doctors or nurses supervise certain patients taking their medications, which is a common practice for patients taking antibiotics for tuberculosis, for example.
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The new product, which will be sold as Abilify MyCite, can be swallowed just like any other pill. Self-reported mood information can also be shared via the app, if the patient chooses.
Experts say the technology could be a useful tool but it will also change how doctors relate to their patients.
The US Centers for Disease Control and Prevention estimates that 6.7% of American adults experienced a major depressive episode in the past 12 months, while lifetime prevalence for bipolar disorder is almost 4% and for schizophrenia almost 1%.
The Japanese drugmaker has not said how it will price the digital pill.
The landmark approval is the latest in an expansive rethinking of what constitutes a treatment.