Saturday, 18 November, 2017

United States approves digital pill that tracks when patients take it

PavelKant  Shutterstock PavelKant Shutterstock
Sammy Stanley | 15 November, 2017, 00:57

Smart pills are a thing and they've come one step closer to entering the mainstream after the FDA approved a pill packed with a digital sensor for the first time in the US. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.

"The FDA supports the development and use of new technologies in prescription drugs, and is committed to working with companies to understand how technology can benefit patients and prescribers", said Mitchell Mathis of the FDA's Center for FDA Drug Evaluation and Research.

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 application for aripiprazole with the embedded sensor was originally accepted by the FDA for review in September 2015, which was followed by a complete response letter requesting more information on the digital drug. The pill is created to track if patients are taking their medication.

Patients would be able to track their dosage on their smartphone and allow their doctors access through a website.

Abilify MyCite is not approved for patients with dementia-related psychosis; it has a Boxed Warning that taking this medication puts patients with dementia-related psychosis at an increased risk of death.

What are some potentially unsafe risks of Abilify MyCite? The label also warns of increased risk of suicidal thinking and behavior among children, teens and young adults.

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.

Prior to initial patient use of the product, the patient's health care professional should facilitate use of the drug, patch, and app to ensure the patient is capable and willing to use the system.

The FDA approval for Abilify MyCite's pill could lead the way for other electronic pills to become available that'll be able to treat other health issues. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology.

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