FDA Approves First Digital Pill for Psychiatric Conditions

Bryan Strickland
November 15, 2017

USA regulators have approved the first pill that contains a digital tracking sensor to alert doctors and caregivers as to whether a patient is taking a medication as scheduled. The agent and sensor is approved for schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as an add-on treatment for depression in adults.

A message from the pill's sensor is sent to a wearable patch, which transmits the information to a mobile app where patients can track the ingestion of medication on their smartphones.

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 hasn't been proven to improve patient compliance with taking medication on a prescribed schedule, the FDA stressed. 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.

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

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.

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"Abilify MyCite should not be used to track drug ingestion in "real-time" or 'during an emergency", said the statement, "because detection may be delayed or may not occur". The pill has an embedded ingestible sensor that records when the medication is taken.

The Abilify MyCite approval is a bigger breakthrough for Proteus, which has been working on drug-device combo pills for years. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.

Patients taking Abilify MyCite should be monitored for worsening or emerging suicidal thoughts and behaviors.

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. The sensor is able to track when the pill was taken, the dosage, and a plethora of other metrics similar to the information a fitness tracker might gather, such as activity levels, sleep patterns, and heart rate.

The sensor is the size of a grain of sand and made from magnesium and copper, according to Proteus Digital Health, the maker of the technology.

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