FDA approves first 'digital pill' to track patients

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Also, patients can give their physicians or caregiver's permission to access this data through a web-based portal.

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

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. And the drug shouldn't be used in an attempt to track "real-time" ingestion, since detection could be delayed, the agency added. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology.

What is the pill approved to treat?


As with similar antipsychotic drugs, Abilify MyCite's label will include a boxed warning that elderly people with dementia-related psychosis are at increased risk of death if they take this medication, the FDA said.

Abilify MyCite's future isn't certain, however. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors.

According to Higuchi, the Abilify MyCite will be rolled out in phases to allow them to gather and respond to feedback provided by patients and health care providers.

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. Skin irritation at the site of the MyCite patch placement may occur in some patients.


"This approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies", said Tatsuo Higuchi, representative director and president for Otsuka Pharmaceuticals.

The Abilify pill was first approved by thee Food and Drugs Administration (FDA) back in 2002, to treat schizophrenia and the sensor technology was approved for marketing in 2012.

The system has three main components: the pill itself, a patch that detects and records the time and date the pill was ingested and tracks other physiological data, and a smartphone app that allows gathered data to be viewed.


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