Otsuka and Proteus Resubmit Application for Combination Product

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

The ingestible sensor activates when it reaches stomach fluids and communicates with a wearable sensor that records physiological data.

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.