The treatment is called Abilify MyCite, which is meant to treat schizophrenia, acute treatment of manic and mixed episodes associated with bipolar disorder, and for use as an add-on treatment for depression in adults.
The Abilify MyCite smart pill, which is made up of an aripiprazole tablet and an ingestible sensor, is able to record when a patient has taken their medication.
The decision approves the Ability MyCite system as a whole - both Abilify and Proteus Health's sensor and patch had previously been cleared individually in the US.More news: Student sit-in planned at Canadore College
A patient ingests the pill, and a sensor inside the pill activates when it reaches the stomach fluids, sending a message to a wearable patch.
The information can also be sent to the prescribing doctor, if the patient consents to this. Medication adherence is a problem when treating patients with severe mental health disorders, because patients may not like side effects or may stop taking medication once they feel better.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, in a statement Monday afternoon.More news: Jimmy Fallon pays tearful tribute to his mother
In addition to lacking data supporting improvements in adherence, the FDA also noted that the patch and sensor should not be used in an emergency to ensure treatment has been taken.
In clinical trials establishing the efficacy of aripiprazole, the most common adverse events were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.
Though it's not approved for elderly patients diagnosed with dementia-related psychosis, the new technology still comes with a Boxed Warning alerting healthcare professionals that elderly patients diagnosed with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. The Boxed Warning also warns that if children, adolescents and young adults mix antidepressants and Abilify MyCite, it will increase their risk of suicidal thinking and behavior.More news: De La Hoya calls out McGregor, talks return
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