USA approves first pill with digital tracking device
USA approves first pill with digital tracking device
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14 November, 2017, 20:05
The pill is a joint effort between Otsuka Pharmaceutical, maker of Abilify, and Redwood City, California-based Proteus Digital Health, which developed the sensor.
"The approval of Abilify, the first digital medicine system, means that for the first time in my years of experience as a psychiatrist, there is an innovative way to provide individuals with serious mental illness, and selected members of their families and care teams, with information on objective medication taking patterns to help inform the patient's illness management and personalized treatment plan".
The Food and Drug Administration has approved the first drug that can digitally track whether patients have taken their medicine.
In granting approval this time around, FDA makes note that Abilify MyCite's ability to improve patients' compliance with their treatment regimen hasn't yet been proven. The patch and sensor is manufactured by the company Proteus Digital Health and aripiprazole marketed by Otsuka Pharmaceutical. By allowing physicians to track a patient's use, Nath said he hopes to avert "dramatic and immediate health-care crises, such as for schizophrenia patients where missing medicines can result in a psychotic break which will land them in an ER". "The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how this technology might benefit patients and prescribers".
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.
The sensor in the pill activates and communicates to the wearable patch when it comes in contact with stomach fluid, and then is digested and eliminated.
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, in a statement Monday afternoon.
The Otsuka website notes, "It can take 30 minutes to 2 hours to detect ingestion of the tablet". Web-based dashboards are provided to healthcare providers and caregivers to view a summary of the information.
There's good reasons as to why tracking whether people living with schizophrenia take their medication could be helpful. If the MyCite app is unable to show if the pill was ingested, a repeat dose is not advised. Patients should be monitored for worsening and emergence of suicidal thoughts and actions.
In the long run, such digital pills can also be used to manage patients with other complicated treatment routines, such as diabetes or heart conditions.
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