Otsuka, Proteus Digital Health Refile for Digital Medicine


Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health report that the US Food and Drug Administration (FDA) has acknowledged receipt of their new drug application (NDA) resubmission for a digital medicine, the drug-device combination product of Abilify (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. The NDA resubmission will now be reviewed by the FDA, with an anticipated action date by the agency in the fourth quarter of 2017.

The FDA requested additional information, including further human factors investigations. The goal of human factors testing is to evaluate use-related risks and confirm that individuals can use the system safely and effectively.

Abilify is a dopamine partial agonist and is approved for the treatment of schizophrenia in adults, for the acute treatment of manic or mixed episodes associated with bipolar I disorder as a monotherapy and as an adjunct to lithium or valproate in adults, and for use as an adjunctive therapy to antidepressants in adults with major depressive disorder who have had an inadequate response to antidepressant therapy.

If approved as a digital medicine, the sensor embedded in the table would measure patient medication-taking patterns as well as select physiological data and self-reported behavioral information. With the patient’s consent, this information could be shared with his/her 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. This 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 an adjunctive therapy for the treatment of major depressive disorder.

The Proteus ingestible sensor activates when it reaches stomach fluids and communicates with a  patch, which is a wearable sensor that detects and records the ingestion of the Abilify tablet, and select physiological data, such as activity level. A mobile patient application, or medical app, displays the data collected by the patch to allow individuals to review their objective medication intake and activity level, as well as enter self-reported measures of rest and mood. A web-based portal for healthcare professionals and selected family and friends displays this information for the duration of treatment.

Source: Proteus Digital Health

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