Proteus Seeks EMA Approval on Ingestible Sensor

October 16, 2015
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Applied Clinical Trials

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 draft qualification opinion on “Ingestible sensor system for medication adherence as biomarker for measuring patient adherence to medication in clinical trials.”

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 announced that its InForm EDC solution was integrated with the Proteus Digital Health Feedback System to form the InForm Medication Adherence Insights Cloud Service. The service captures and integrates adherence data from the Proteus Digital Health feedback system directly into an electronic data capture system.

And in mid-September Otsuka Pharmaceutical and Proteus announced that FDA accepted for review its NDA for the combination product of Abilify (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. Abilify is an anti-psychotic used to treat adults with schizophrenia, manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorder in adults.

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 variety of reasons. If approved and prescribed, it provides greater ability for patients, caregivers and HCPs to help manage this condition.

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.

 

Here we list the top problems related to non-adherence in clinical trials.

 

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