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# Otsuka, Proteus Re-file NDA on ‘Digital’ Abilify
- URL: https://www.fdaweb.com/otsuka-proteus-re-file-nda-on-digital-abilify/
- Published: 2017-05-24T12:00:00.000Z
- Updated: 2026-09-14T22:25:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138774

Otsuka Pharmaceutical and Proteus Digital Health have resubmitted an NDA for a drug-device combination product using Abilify (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. The companies are expecting a user fee review action in the fourth quarter.

In 4/2016, FDA issued a complete response letter for their digital medicine, which was submitted as a system that measures medication adherence to aripiprazole, indicated for treating schizophrenia and manic and mixed episodes associated with bipolar I disorder, and as an adjunctive treatment for major depressive disorder. The letter requested additional information, including data on the performance of the product under the conditions in which it is likely to be used, and further human factors investigations. “The goal of human factors testing is to evaluate use-related risks and confirm that users can use the device safely and effectively,” the companies said at the time.

  
The companies say that, if approved, the product would “securely measure patient medication-taking patterns, as well as select physiological data and self-reported behavioral information. This information would help enable individuals along with their healthcare professional team to better manage their serious mental illness. With the patient’s consent, this information could be shared with their healthcare professional team and selected family and friends, with the goal of allowing physicians to be more informed in making treatment decisions that are specific to the patient's needs.”