- Otsuka Pharmaceutical (OTCPK:OTSKF)(OTCPK:OTSKY) resubmits its New Drug Application (NDA) to the FDA seeking approval of a drug-device combination of antidepressant ABILIFY (aripiprazole) embedded with an ingestible sensor made by Proteus Digital Health (Private:PRDI) in a single tablet. The agency requested addition information, principally human factors studies, in response to the original filing.
- The ingestible sensor, the size of a grain of sand and activated by stomach fluids, transmits physiological data to a sensor worn by the patient. A mobile app displays the data allowing the individual to review his/her medication intake and activity level in addition to self-reported measures of rest and mood. Healthcare professionals and selected family members and friends can view the information via a web-based portal.
- Both ABILIFY and the Proteus sensor have been individually approved by the FDA.
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Original article