The FDA has issued a complete response letter for Digital Medicine (Otsuka Pharmaceutical/Proteus Digital Health), a drug/device combination product that combines the atypical antipsychotic drug aripiprazole (Abilify, Otsuka) with the FDA-cleared Proteus ingestible sensor embedded in a single tablet at the point of manufacture.
In the new drug application (NDA) submitted by Otsuka and Proteus, the product was described as a system that measures medication adherence to aripiprazole as a treatment for schizophrenia, as an acute treatment of manic and mixed episodes associated with bipolar 1 disorder (BP1), and as an adjunctive treatment for major depressive disorder (MDD).
After completing its review of the NDA, the FDA requested additional clinical 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 to confirm that patients can use the device safely and effectively.
Aripiprazole was the first available dopamine partial agonist. It is indicated as a treatment of schizophrenia, as an acute treatment of manic or mixed episodes associated with BP1, and as an adjunctive treatment of MDD. Aripiprazole tablets are available in 2-mg, 5-mg, 10-mg, 15-mg, 20-mg, and 30-mg strengths.
The Proteus ingestible sensor and wearable patch have been cleared by the FDA for use in the United States.
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