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News Worms


FDA approves smart pill that lets doctors know when it's been swallowed

FDA approves smart pill that lets doctors know when it's been swallowed

"The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers", said Mitchell Mathis of the FDA's Center for Drug Evaluation and Research.

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.

"It is important to note that Abilify MyCite's prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown", the FDA said in the November 13 statement. The sensor is able to track when the pill was taken, the dosage, and a plethora of other metrics similar to the information a fitness tracker might gather, such as activity levels, sleep patterns, and heart rate.

The new product, which will be sold as Abilify MyCite, can be swallowed just like any other pill.

Aripiprazole is approved with a Boxed Warning concerning an increased risk of death when used as a treatment for elderly patients with dementia-related psychosis. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.

The patch then transmits the information from the sensor to a mobile application so individuals can track the ingestion of the medication on their smartphone. 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 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. A report from the IMS Institute for Healthcare Informatics estimates that the cost of patients not taking their medication correctly is about $100 billion each year. Abilify treats depression, bipolar disorder, and schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

The pill, created by Otsuka Pharmaceutical and Proteus Digital Health, is a version of Abilify, made by Otsuka, Bloomberg Technology reported.

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