FDA Accepts First Digital Drug NDA for Review
Otsuka and Proteus Digital Health announced that the Food and Drug Administration (FDA) has accepted for review and filling the New Drug Application (NDA) for the combination product of Abilify (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. This is the first time an FDA-approved medication has been combined and submitted for approval with a sensor within the medication tablet.
The Abilify tablet contains an ingestible sensor that communicates with a wearable sensor patch and a medical software application for measuring adherence in the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorder in adults. When Abilify is taken, the ingestible sensor sends a signal to the wearable Proteus patch after it reaches the stomach. The patch records and time-stamps the information from the ingestible sensor in addition to collecting other patient metrics, including rest, body angle and activity patterns. This information is recorded and relayed to patients on a mobile phone or other Bluetooth-enabled device, and only with their consent, to their physician and/or their caregivers.
If approved by the FDA, this drug-device product can provide the patient with a treatment option to help manage symptoms while allowing the caregiver and healthcare professional to measure medication adherence and other patient metrics.
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