The Food and Drug Administration has approved the first drug in the United States with a digital ingestion tracking system, in an unprecedented move to ensure that patients with mental illness take the medicine prescribed for them.
The drug Abilify MyCite, developed by Otsuka Pharmaceutical Co. Ltd, was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor, made by Proteus Digital health, was approved for marketing in 2012. 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.
In a portion of the statement to address privacy concerns, the FDA said the wearable patch that comes with the medication “transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. The FDA said the product is designed for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with a bipolar disorder and for use as an add-on treatment for depression in adults.