U.S. FDA Accepts First Digital Medicine New Drug Application for Otsuka and Proteus Digital Health

September 14, 2015
  • The first Digital Medicine, a drug/device product, combines Otsuka’s ABILIFY® (aripiprazole) for serious mental illness, embedded with the Proteus® ingestible sensor in a single tablet to digitally record ingestion and, with patient consent, share information with their healthcare professionals and caregivers
  • Otsuka and Proteus are pursuing a regulatory filing for a drug-device combination across multiple divisions of the FDA to support the unique system
  • First opportunity to demonstrate the potential of Digital Medicines to provide an objective measure of medication adherence and physiologic response

TOKYO, JAPAN and REDWOOD SHORES, CALIF. – September 10, 2015 Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) today announced that the United States Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) for the combination product of ABILIFY® (aripiprazole) embedded with a Proteus® ingestible sensor in a single tablet is sufficiently complete to allow for a substantive review and is considered filed as of September 8, 2015.

This is the first time an FDA-approved medication (ABILIFY) has been combined and submitted for approval with a sensor within the medication tablet (the Proteus ingestible sensor) to measure actual medication-taking patterns and physiologic response. This objective information is communicated to the patient – and with the consent of the patient – to the patient’s physician and/or caregiver. Digital Medicines may enable improved patient medication adherence and better informed physician decision-making to tailor treatment to the patient’s needs.

Read the full article at Proteus Digital Health.

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