Published: Thu, November 16, 2017
Medicine | By Earnest Bishop

FDA approves digital ingestion tracking system drug

FDA approves digital ingestion tracking system drug

Officials with the US Food and Drug Administration have approved aripiprazole tablets with a sensor to digitally track whether patients with schizophrenia, bipolar I disorder, and depression have taken their medication (Abilify MyCite).

Monday's hard-won approval could come as a big boost for Otsuka, which had lost market share after Abilify went generic but will now have a way to make the product stand out. Made by Japan-based Otsuka Pharmaceutical Co., the medication system is meant to treat schizophrenia, bipolar I disorder and depression in adults.

Schizophrenia, a psychotic disorder, causes symptoms of delusions and hallucinations, while bipolar patients may experience alternating episodes of mania and depression, a persistent sadness.

It is important to note that Abilify MyCite's prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown.

Teens and young adults who are taking antidepressants are at increased risk of suicidal behavior and thoughts when taking the medication, cautions a boxed warning; they should be monitored closely. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.

The sensor is digested and eliminated from the body. The patch then sends the data to a smartphone application; the data can then be shared with selected family members or caregivers. It is also used in the treatment of major depressive disorders and irritability linked to autism.

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The tiny sensor, made by a company called Proteus, is about the size of a grain of sand.

President and chief executive officer of Proteus Digital Health, Andrew Thompson adds:"The time is right for the category of Digital Medicines to be available to appropriate patients with serious mental illness".

Dr. Michael Birnbaum, director of the Early Treatment Program (for psychosis) at Lenox Hill Hospital in NY, said the "continual adoption of new and innovative technological tools is ubiquitous". "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 acknowledged that some people may initially "feel wary" of ingesting a sensor. "So, if someone with schizophrenia knows they frequently forget to take their meds, they may want to elect this one, so they, or a parent or someone they trust, can be notified if they forget". The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

So, what does this mean for mental health?

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