First digital pill rejected by FDA

The US Food and Drug Administration (FDA) has rejected the first medication that combines drugs with a digital sensor that measures medication adherence

The FDA issued and Complete Response Letter (CRL) for Otsuka Pharmaceutical (Otsuka) and Proteus Digital Health’s (Proteus) digital medicine.

The digital medicine combined Otsuka’s Abilify (aripiprazole) with the FDA-cleared Proteus ingestible sensor and embedded both in a single tablet at point of manufacture.

The digital medicine was submitted as a system that measures medication adherence to aripiprazole to be indicated for the treatment of schizophrenia.

The FDA has completed its review of the digital medication and 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.

Robert McQuade, executive vice president and chief strategy officer, Otsuka pharmaceutical development and commercialisation, said: “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.

“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.”