U.S. approves digital pill that tracks when patients take it (4578, MDT)

by Leslie Wood November 16, 2017, 1:59
U.S. approves digital pill that tracks when patients take it (4578, MDT)

FDA announced it has approved Abilify MyCite, a pill with a sensor that digitally tracks whether a patients has ingested the medication, on November 13.

The FDA has approved the use of the system with the popular drug Abilify, which is used to treat a variety of mental illnesses and disorders including depression and bipolar disorder.

This patch sends the ingestion data to a smartphone app so patients are able closely to track the ingestion of medication. The patient's doctor and up to four other people chosen by the patient, including family members, can access the information. Doctors having knowledge of the frequency and use of a patient's medication can help with understanding why a prescription is working or not and ensuring proper dosages are set.

Called Abilify, the purely chemical version of the drug actually received FDA approval over a decade ago to treat patients with schizophrenia and bipolar disorders.

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 US healthcare system an estimated $200 billion per year.

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

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"This approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies", Otsuka president and representative director Tatsuo Higuchi said. "Our rollout of the Abilify MyCite system will be done in phases to obtain, and respond to, feedback from healthcare providers and their patients". The drug will help doctors in monitoring if their patients are taking their medicines on time.

FDA approves pill with sensor that digitally tracks if patients have ingested their medication: New tool for patients taking Abilify [press release].

About the size of a grain of salt, the sensor has no battery or antenna and is activated when it gets wet from stomach juices. The agency also noted that the product has not shown an ability to improve patient compliance with a treatment regimen. But, the app that works with the digital drug system allows patients to revoke access to data at any time. The drug Abilify (with or without the digital sensor) can cause side effects including nausea, vomiting, constipation, anxiety, headache and uncontrollable movements.

It is not approved for use in elderly patients with dementia-related psychosis.

The US Centers for Disease Control and Prevention estimates that 6.7% of American adults experienced a major depressive episode in the past 12 months, while lifetime prevalence for bipolar disorder is almost 4% and for schizophrenia almost 1%.


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