Otsuka's plans to combine its antipsychotic drug Abilify with Proteus' digital pill to measure adherence have suffered a setback in the US after the FDA declined to approve the drug/device tie-up.

The regulator instead issued a Complete Response Letter for the 'digital medicine' requesting additional information, including data on the product's performance under the conditions in which it is likely to be used.

The FDA also wants 'human factors investigations', to evaluate any use-related risks with the Otsuka/Proteus device and to confirm patients will be able to use it safely and effectively.

Otsuka had submitted the device for approval to measure medication adherence to Abilify (aripiprazole) in patients with schizophrenia, as an acute treatment of manic and mixed episodes associated with bipolar I disorder and as an adjunctive treatment for major depressive disorder (MDD).

Robert McQuade, executive vice president and chief strategy officer, Otsuka Pharmaceutical Development & 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.”

Proteus' digital medicine has, by itself, already been approved by the FDA. The technology uses a tiny sensor that is activated in the stomach and communicates information about how an individual is taking their medication and how their body is responding to therapy.

This information is communicated via a patch the patient wears to enable more effective monitoring of patients and to help them take charge of their health.

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