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15 November 2017, 01:38 | Rex Hubbard
FDA Approves First Pill With Digital Tracking System
It might sound creepy, but USA regulators have approved a drug that can digitally track whether patients have taken their medicine.
The pill, called Abilify MyCite, adds a tiny sensor, no larger than a grain of sand, made of silicon, copper, and magnesium inside a tablet of Abilify, a drug used to treat mental disorders like schizophrenia, bipolar disorder, and is used in conjunction with antidepressants to treat depression.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.
According to the news release, the FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd.
The FDA noted that Abilify MyCite has not demonstrated an ability to improve patient compliance; therefore it should not be used to track medication ingestion in real-time or during an emergency, as detection may be delayed or may not occur.
The information can also be accessed by caregivers and physicians through a web-based portal, but patients have to grant access. The pill has an embedded ingestible sensor that records when the medication is taken.
The new product, which will be sold as Abilify MyCite, can be swallowed just like any other pill.
Abilify MyCite includes 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. The medication must also be dispensed with a patient Medication Guide with information about the drug's uses and risks. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.
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.
The pill and its digital companions, now FDA-approved as Abilify MyCite, aren't likely to make a big difference to Otsuka's Abilify sales-certainly not immediately, given its plans for a limited initial launch. The technology in the sensors and the patch were developed by Proteus Digital Health. This first US approval could bode well for other new products in the works, including sensor-embedded versions of generic blood pressure pill lisinopril and the standard diabetes drug metformin.
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