FDA issues Complete Response Letter to Otsuka and Proteus relating to their Digital Medicine system which measures adherence to treatment for schizophrenia, depression and bipolar disorders

Otsuka Pharmaceutical Co and Proteus Digital Health have announced that the FDA has issued a Complete Response Letter (CRL) for their Digital Medicine, a drug/device combination product, which combines Otsuka’s Abilify (aripiprazole), an atypical antipsychotic, with the FDA-cleared Proteus ingestible sensor embedded in a single tablet at point of manufacture. The NDA was submitted as a system that measures medication adherence to aripiprazole to be indicated for the treatment of schizophrenia, as an acute treatment of manic and mixed episodes associated with Bipolar I Disorder (BP1) and as an adjunctive treatment for Major Depressive Disorder (MDD).

The FDA has completed its review and has requested additional information, including data regarding the performance of the product under the conditions in which it is likely to be used, and further human factors investigations. The goal of human factors testing is to evaluate use-related risks and confirm that users can use the device safely and effectively.

Comment: 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.