FDA Approves Schizophrenia Medication With Digital Ingestion Sensor

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USA 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.

Monday's FDA approval for Abilify MyCite is for treatment of schizophrenia, bipolar disorder and as an add-on treatment for depression in adults.

In a statement on Monday, the FDA said that the digitally-enhanced drug "works by sending a message from the pill's sensor to a wearable patch".

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.

And Otsuka is aware that Abilify MyCite is a more complicated product than the usual pill, and it'll be more hard to market, too.

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. Data from the patch sends the information to a mobile app, which can be monitored by patients, caregivers, and physicians via web portal.

Aripiprazole tablets are prescribed for serious mental conditions, such as schizophrenia and mania.

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What are some potentially unsafe risks of Abilify MyCite?

Children, adolescents and young adults taking antidepressants are at an increased risk of suicidal thinking and behavior.

Proteus has been working on the pill tracking system for many years and the sensor used in Abilify MyCite was first cleared for use by the FDA in 2012. The atypical antipsychotic drug is already available as a cheap generic, and doctors are already using an injectable, long-lasting version-Abilify Maintena-to manage patients who have problems sticking to a daily pill regimen. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.

Abilify MyCite is not approved for treating patients with dementia-related psychosis.

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.

But until now, the FDA had not approved a sensor-pill combination.

Abilify is a drug developed by Otsuka Pharmaceuticals whereas the sensor was created by a company called Proteus Digital Health.

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