Proteus Seeks EMA Approval on Ingestible Sensor
EMA and FDA regulatory approvals are just the latest events demonstrating the industry’s growing interest in medication adherence measurement in clinical trials, as well as healthcare in general.
In early August, the EMA issued a
Specifically, Proteus requested the EMA to consider the use of its technology “as a ‘qualified method’ for measuring adherence and associating relevant physiologic and behavioral parameters, such as indications of therapeutic response.” Public consultation began September 15, and ends on October 26. The Proteus ingestible event marker is approved in the EU and the United States for use as a medical device. But this application furthers the products use in clinical trials in Europe. The FDA granted Proteus a label expansion to allow the product to be used to measure medication adherence in early July.
These regulatory approvals are just the latest events demonstrating the industry’s growing interest in medication adherence measurement in clinical trials, as well as healthcare in general.
Earlier this year, Oracle
And in mid-September Otsuka Pharmaceutical and Proteus
This is the first time an FDA-approved medication has been combined and submitted for approval with a sensor to measure actual medication-taking patterns and physiologic response. This information is communicated to the patient – and with the consent of the patient – to the patient’s physician and/or caregiver. It is estimated that 40% of schizophrenic patients do not adhere to their medications for a
According to Proteus, the ingestible sensor sends a signal to the wearable Proteus patch after it reaches the stomach. The patch records and time-stamps the information from the ingestible sensor in addition to collecting other patient metrics, including rest, body angle and activity patterns. This information is recorded and relayed to patients on a mobile phone or other Bluetooth-enabled device, and only with their consent, to their physician and/or their caregivers. Patients view the information using a secure and local software application on their mobile phone or device. Physicians and caregivers view the data using secure web portals.
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