FDA approves first 'trackable' pill Abilify

FDA approves first 'trackable' pill Abilify

About the size of a grain of sand, the sensor activates when it comes into contact with stomach fluid.

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. It is approved for use in treating schizophrenia and bipolar disorder and as an add-on therapy for adult depression.

Whatever way you look at it, this is a major breakthrough for digital health and we're sure now that the FDA has approved one smart pill, we'll soon be flooded by more of them over the coming years. A resubmission of the new drug application was accepted by the agency in May 2017.

Although the sensor can alert caregivers, the makers of Abilify, Japan-based Otsuka Pharmaceutical, said it is unclear whether the tracking device will actually help improve patients' ability to take their medication daily as prescribed. The FDA said in a statement Monday that the digitally-enhanced medication "works by sending a message from the pill's sensor to a wearable patch".

"The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers", he added.

Aripiprazole was initially approved by the FDA in 2002 as a treatment for patients with schizophrenia.

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Others have raised concerns about privacy and physician-patient trust, however.

The treatment intends to address issues with patients taking their medication correctly.

The US-based IMS Institute estimates some $200bn (£152bn) was lost in 2012 through improper or unnecessary use of medicine. In general, communication between the pill, patch, and app are delayed, and data are not available in "real-time", according to the FDA.

The most common side effects of aripiprazole include nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.

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. The Boxed Warning also warns that if children, adolescents and young adults mix antidepressants and Abilify MyCite, it will increase their risk of suicidal thinking and behavior. Skin irritation at the site of the MyCite patch placement may also occur.