First Digital Pill Approved by FDA Includes Medication Sensor

15 November, 2017, 00:55 | Author: Hope Soto

U.S. regulators have approved the first pill with a sensor, which can track whether or not patients have taken their medicine.

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.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Dr. Mitchell Mathis, director of the agency's Division of Psychiatry Products.

Abilify MyCite's approval was granted to Japan's Otsuka Pharmaceuticals.

The system sends a message from the pill's sensor to a wearable patch.

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Aripiprazole is used to treat multiple mental mood disorders, including bipolar disorder and schizophrenia. The sensor that is used along with the medication was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a milestone for the FDA.

Abilify MyCite's future isn't certain, however.

Abilify Mycite's prescribing information notes the ability of the product to improve patient compliance with their treatment regimen has not been shown. The drug contains a warning box for professional healthcare workers that elderly patients with dementia-related psychosis are treated with antipsychotic drugs. It's also been pointed out that as schizophrenia symptoms often include paranoia, it's unlikely that every patient will be willing to take a meditation that monitors behavior in such a way. In Abilify MyCite, skin irritation at the site of the MyCite patch may also occur.

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. This sensor is obviously ingested when the patient takes their medication; it provides data to a related patch the patient wears while taking the meds. In September, the FDA approved the first mobile app to treat certain substance use disorders, developed by the Boston company Pear Therapeutics.

The technology is the product of research between Japanese pharmaceutical company Otsuka and Proteus Digital Health, and is created to solve the problem of people missing medicine doses, which costs the USA healthcare system an estimated $200 billion per year.


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