U.S. FDA Accepts First Digital Medicine Application; Technology Combines Abilify With Proteus Sensors

News Report | September 20, 2015

On September 8, 2015, the United States Food and Drug Administration (FDA) accepted a new drug application (NDA) for a drug-device for measuring adherence to antipsychotic treatment for adults with schizophrenia, bipolar disorder, or major depressive disorder. The NDA was submitted by Otsuka and Proteus Digital Health, Inc. for an oral tablet that combines Otsuka’s branded antipsychotic Abilify (aripiprazole) with an embedded ingestible sensor device that digitally records ingestion. With the consumer’s consent, the sensor communicates with a wearable sensor patch and a medical software application to share information with the consumer’s care team about when the medication was taken. The system also tracks the consumer’s physiological responses, such as sleep patterns and physical activity levels.

The FDA has approved Abilify for maintenance treatment of adults diagnosed with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for adults diagnosed with major depressive disorder. In their announcement about the NDA, Otsuka and Proteus said the drug-device, with consumer consent, could be used to help caregivers and medical professionals measure the consumer’s medication taking patterns. If the FDA approves the NDA, Otsuka will embed the Proteus ingestible sensor into Abilify oral tablets at the point of manufacture.

In October 2013, Proteus Digital Health submitted an application to the FDA for 510(k) marketing clearance for the ingestible device, formally called the Proteus Patch Including Ingestible Sensor. The FDA approved the application in July 2015. The application described the system components as follows:

  • The Proteus Patch is a body worn sensor that collects physiological and behavioral metrics, such as heart rate, activity, body angle relative to gravity, and time-stamped, user-logged events generated by swallowing the Proteus Ingestible Sensor.
  • The Ingestible Sensor is embedded inside an oral tablet. After the sensor reaches the stomach, it activates and communicates its presence and unique identifier to the patch.
  • The Patch stores and wirelessly sends the physiological and ingestion data to a secure database. The consumer has control over who can view the data.
  • Consumers view the information using a secure and local software application on their mobile phone or other Bluetooth-enabled wireless device. Physicians and caregivers view the data using secure web portals.

The Proteus Ingestible Sensor was tested in 412 people who ingested more than 20,000 sensors. No serious adverse events were recorded, and 1% or fewer people reported non-serious adverse events, such as nausea. The Proteus Patch was tested in 492 people, representing over 6,400 days of use. None experienced a serious adverse event, and about 12% experienced a self-limited localized rash at or near the patch placement site. The ingestible sensor was detected in 97.3% of ingestions, with 100% correct identification.

Otsuka and Proteus entered a worldwide product development partnership in 2012 to develop drug-devices for two undisclosed therapeutic areas. The partnership announcement indicated that Otsuka also intended to use the Proteus feedback system in clinical research and development. Financial terms of the partnership were not disclosed.

A link to the full text of “Proteus Digital Health 510 K Clearance Application Summary For Ingestible Event Marker Device” may be found in The OPEN MINDS Circle Library at www.openminds.com/market-intelligence/resources/021714proteus510kapp.htm.

A feasibility study testing the Proteus system for monitoring medication adherence among 28 adults diagnosed with schizophrenia took place from May 2010 to May 2011. The details of the study, “Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study (EMITTER3PSY)” are posted at https://clinicaltrials.gov/ct2/show/NCT01804257 (accessed September 16, 2015).

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