FDA requests more data on atypical antipsychotic with ingestible sensor

The FDA has issued a complete response letter for Digital Medicine, a drug/device combination product from Otsuka Pharmaceutical Inc. and Proteus Digital Health that combines an atypical antipsychotic and an ingestible sensor.

Specifically, the product contains Abilify (aripiprazole, Otsuka America Pharmaceutical, Inc.) and an FDA-approved ingestible sensor embedded in a single tablet from Proteus.

A new drug application was submitted for the drug/device combination as a system that determines medication adherence to aripiprazole for treatment of schizophrenia, as an acute treatment for bipolar I disorder with manic and mixed episodes and as an adjunctive treatment for major depressive disorder.

Upon review completion, the FDA has requested more information, including performance data and further human investigations to determine safety and efficacy of the product.

“While we are disappointed in the FDA’s decision not to approve this Digital Medicine at this time, both Otsuka and Proteus are committed to working with the FDA to address its questions and provide the additional data that has been requested,” Robert McQuade, PhD, executive vice president and chief strategy office at Otsuka Pharmaceutical Development & Commercialization Inc., said in a press release. “We believe in the potential of this product to help people with serious mental illness manage their daily medication, which remains a serious unmet need.”