Dr. Mitchell Mathis of the FDA says officials support "use of new technology in prescription drugs and is committed to working with companies to understand how the new technology might benefit patients and prescribers".
The pill's sensor sends a message to a wearable patch that transmits the information to an app, allowing patients to track the medication's ingestion on their phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.
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%. Bipolar patients may experience alternating episodes of mania and depression, a persistent sadness. Moreover, FDA commented that ABILIFY MYCITE should not be used in "real time" or during an emergency as the detection might take longer time or might not occur at all.
Teens and young adults on antidepressants are at increased risk of suicidal behaviour and thoughts, cautions a boxed warning; and need to be monitored closely. Abilify MyCite must be dispensed with a patient Medication Guide that describes important information about the drug's uses and risks.
While Abilify MyCite is elective for patients and consent is needed, Rudy Caseres, a mental health advocate who is a part of The Mighty's mental health community, said he worries about the implications of technology like this. The common adverse events associated with the sensor were related to the patch, and were predominantly skin irritation.
WEDNESDAY, Nov. 15, 2017 (HealthDay News) - The first drug in the United States with a digital ingestion tracking system has been approved by the U.S. Food and Drug Administration. The CEO of Proteous Digital Health, Andrew Thompson, said "this technology can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way".
Abilify MyCite will be available starting in 2018.
The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The drug tracking system is the first of its kind in the U.S.
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