FDA ‘Complete Response’ on Digital Medicine Combo Product

FDA has issued Otsuka Pharmaceutical Co. and Proteus Digital Health a complete response letter for their Digital Medicine, a drug/device combination product that combines Otsuka’s Abilify (aripiprazole), an atypical antipsychotic, with the FDA-cleared Proteus ingestible sensor embedded in the tablet. The NDA was submitted as a system that measures medication adherence to aripiprazole, and it is indicated for treating schizophrenia and manic and mixed episodes associated with bipolar I disorder, and as an adjunctive treatment for major depressive disorder.

The letter has requested additional information, including data on 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,” the companies say.