Digital Abilify pill secures first-of-its-kind FDA approval

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Digital Abilify pill secures first-of-its-kind FDA approval

US regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology. The agency says the digitally enhanced medication "works by sending a message from the pill's sensor to a wearable patch".

"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. That information produced can also be accessed by caregivers and physicians through a web-based portal so they are able to keep track of the patients as well. Labeling information stresses that it has not been proven if tracking such information improves treatment regimens. Since digital Abilify hasn't been shown to improve patient compliance, it should not be used to track drug ingestion in real-time or during an emergency, the FDA said.

The drug is a version of established drug Abilify for schizophrenia, bipolar disorder and depression.

Abilify MyCite is not approved to treat patients with dementia-related psychosis and contains 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.

Forgetfulness and cloudy thinking can be symptoms of the mental health conditions that Abilify is approved to treat, and patients with mental illness are known to struggle to take medication consistently.

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

The FDA-approved pill, Abilify MyCite, consists of aripiprazole tablets, but with a sensor.

Abilify MyCite is not approved for treating patients with dementia-related psychosis. The sensor in Ability MyCite syncs with a smart phone and sends an alert when the medication is ingested via a patch that is worn on the surface of the skin.

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.

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.

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