Otsuka, Proteus re-apply to FDA for digital drug approval

Otsuka and Proteus Digital Health requested FDA approval with an application for the invention.
Otsuka and Proteus Digital Health requested FDA approval with an application for the invention. | File photo

A pioneering prototype blending a mood stabilizer with technology is on the radar for two companies determined to develop a combination drug/device that, if approved by the FDA, could potentially address serious mental health challenges.

Abilify (aripiprazole), marketed by Otsuka Pharmaceutical Co., when embedded with a Proteus-manufactured ingestible sensor, actually enables the product to record and share details of medication ingestion with practitioners and designated family members or friends, making caretaking easier and serving as an objective way to gather data.

The sensor itself is the size of a grain of sand, company representatives said, embedded within each tablet. The sensor is activated when it combines with stomach fluids; it then relays information to a wearable patch that the patient can observe and report on. The data also transmits to an online portal for the extent of the treatment period.

Otsuka and Proteus Digital Health requested FDA approval with an application for the invention. The agency asked for more information, specifically “further human factors investigations” or an assessment of risks involved, in order to ascertain product safety, according to Otsuka representatives.

Officials expect the new drug application (NDA) resubmission to be reviewed by the FDA, with an anticipated response from the agency during the fourth quarter of 2017.  

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Otsuka America Pharmaceutical, Inc. 490 Fleet St Rockville, MD - 20850