USA regulators approve first digital pill to track patients
Nov 14 2017 by Kathy Alvarado
The Abilify pill was first approved by the Food and Drug Administration in 2002 to treat schizophrenia, and the sensor technology was approved for marketing in 2012.
"The FDA supports the development and use of new technologies in prescription drugs, and is committed to working with companies to understand how technology can benefit patients and prescribers", said Mitchell Mathis of the FDA's Center for FDA Drug Evaluation and Research.
The drug-device combination is approved for several of the same indications as regular Abilify, including schizophrenia, add-on therapy for depression in adults, and. acute treatment of manic and mixed episodes associated with bipolar I disorder.
United States regulators have approved the first pill that can be digitally tracked through the body.
In granting approval this time around, FDA makes note that Abilify MyCite's ability to improve patients' compliance with their treatment regimen hasn't yet been proven.
The patch transmits the information to a mobile application where patients can track their dosage on their smartphone and allow their doctors or caregivers to access the information through a website. Additionally, the smart pill should not be used for real-time tracking or during an emergency since detection can be delayed or may not happen, according to the release.
Schizophrenia is a chronic, severe, and disabling brain disorder.
Abilify MyCite contains a Boxed Warning to alert healthcare professionals not to treat patients with dementia-related psychosis.
Abilify MyCite is not approved for treating patients with dementia-related psychosis. 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. The FDA advises that patients should be monitored for this condition.
The information can also be sent to the prescribing doctor, if the patient consents to this.
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.
Choudhry, whose work includes developing predictive analytics initiatives to spot patients who don't take their meds, estimates that almost $300 billion is spent in the US each year in "caring for health conditions that are attributable to nonadherence".
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.
As explained in an FDA news release, the pill contains a sensor that communicates with a wearable patch.