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Medical Devices / Submissions and Approvals

Otsuka and Proteus Digital Health Resubmit Application to FDA for Digital Medicine Device

May 24, 2017
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Otsuka and Proteus have resubmitted a new drug application for the drug-device combination product of Abilify (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet.

The FDA requested additional information, including further human factors investigations.

The digital medicine would be used in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and as adjunctive therapy for the treatment of major depressive disorder.

The ingestible sensor activates when it reaches stomach fluids and communicates with a wearable sensor (patch) that records the ingestion of the Abilify tablet as well as physiological data such as activity level.

A mobile patient application displays the data collected by the patch to allow individuals to review their medication intake and activity level, as well as enter self-reported measures of rest and mood. The information is displayed on a web-based portal. — Cynthia Jessup

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