The US Food and Drug Administration (FDA) has rejected an application from Proteus Digital Health and partner Otsuka for a prescription medication embedded within a monitoring device. The product is a forerunner among a growing health trend for digital self-monitoring (Nat. Biotechnol. 32, 965–966, 2014): a single table combines an ingestible sensor made by Redwood City, California–based Proteus with Tokyo-based Otsuka's antipsychotic Abilify (aripiprazole). The wireless sensor–drug combination tracks when pills are taken and can collect information on patients' physiological responses to help boost adherence and allow treatments to be tailored to the individual. The sensor in the tablet transmits information to a wearable sensor patch, and the data are collected by a medical software application and transmitted to the patient or, with the patient's consent, to clinicians, friends and family (Nat. Biotechnol. 34, 15–18, 2016). Although the Proteus technology has already been cleared in the US and Europe for use in conjunction with existing medicines—though not as a device embedded in a tablet, as in this case—the FDA issued a complete response letter to the Tokyo-based Otsuka and the Redwood City, California–based Proteus in April. The agency is now seeking further confirmation on the sensor–drug combination's performance under the specific conditions in which it is likely to be used, as well as further risk evaluations for users. Abilify is an atypical antipsychotic, and the submitted application was for the device–pill to treat schizophrenia and episodes related to bipolar disorder and as an adjunct treatment for major depression.
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FDA snubs first smart pill. Nat Biotechnol 34, 678 (2016). https://doi.org/10.1038/nbt0716-678
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