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United States regulators approve first digital pill to track patients

14 November 2017

According to the FDA, the Abilify has been approved for the treatment of schizophrenia and bipolar disorder, as well as an add-on treatment for depression.

The FDA approval for Abilify MyCite's pill could lead the way for other electronic pills to become available that'll be able to treat other health issues.

Abilify MyCite does outline some precautions when using it though stating that the smart pill should be not used to track drug ingestion in real-time or during an emergency as detection could be delayed.

"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.

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The ingestible sensor used in the tablets was granted FDA clearance in the de novo category - "an alternative pathway to classify" certain novel medical devices - in 2012.

Otsuka explains, "The system has been designed for the individual with serious mental illness to allow them to record their daily medication intake and have a more informed dialogue with their healthcare team". The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone.

But adherence to prescribed dosing is a big problem, one that some drugmakers have tried to battle for years; patients who don't take their medications don't refill their prescriptions.

The pill is a variant of the drug Abilify from Otsuka Pharmaceutical Co Ltd. Patients can also allow their physicians and caregivers access to their data through the internet.

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The sensor "activates when it reaches stomach fluids and communicates with the patch", said the company. The signal is detected by a plaster-like patch worn on the left hand side of the patient's rib cage which must be replaced every seven days, Andrew Wright, the drug maker's parent company Otsuka America's vice president for digital medicine told the New York Times. Web-based dashboards are provided to healthcare providers and caregivers to view a summary of the information. Sometimes the system might not detect that the medication has been taken. If the MyCite app is unable to show if the pill was ingested, a repeat dose is not advised.

The system offers doctors an objective way to measure if patients are swallowing their pills on schedule, opening up a new avenue for monitoring medicine compliance that could be applied in other therapeutic areas.

The FDA said that being able to track ingestion of medicines prescribed for mental illness may be useful "for some patients", although the ability of the digital pill to improve patient compliance had not been proved.

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United States regulators approve first digital pill to track patients