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New Drug Application for First Digital Medicine Under Review

Companies pursue regulatory filing for drug/device combo

The FDA accepted a drug/device product application combining aripiprazole (Abilify, Otsuka) with Proteus’ ingestible sensor in a single tablet, which will record ingestion and, with the patient’s consent, share the information with caregivers and health care professionals. The application marks the first time an FDA-approved medication has been submitted with a sensor within the drug dosage to measure adherence and response.

The tablet contains an ingestible sensor that communicates with a wearable sensor patch and a medical software app to measure adherence to treatment in adults with schizophrenia and in those with manic and mixed episodes associated with bipolar I disorder, and to measure  adjunctive therapy for major depressive disorder.

When aripiprazole with the embedded ingestible sensor is ingested, the sensor sends a signal to the wearable Proteus patch after it reaches the stomach. The patch records and time-stamps the information from the 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 physicians and/or caregivers. Patients view the information using a secure local software application on their mobile phone or device. Physicians and caregivers view the data using secure web portals.

Source: Otsuka, September 11, 2015

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