FDA Agrees To Consider First Digital Medication Application

Otsuka Pharmaceutical and Proteus Digital Health announced that the FDA has accepted their New Drug Application (NDA) for the drug Abilify, which will be manufactured with an embedded, ingestible sensor that tracks treatment adherence and physiologic response. Both the sensor and Abilify have already received separate FDA approvals, but this marks the first time the FDA will evaluate a sensor-embedded, clinically approved drug. Proteus’ sensor is a silicon chip, approximately the size of a grain of sand, that uses digestive juices to generate a voltage that can be read by detector patch attached to the surface of the skin. The sensor can collect and send a variety of different information — including whether or not the patient took their medication on time and how the patient’s body responded to the dose — and transmit that information to healthcare providers. In 2012,Nature reported that the sensor was approved by the FDA, but with placebo pills, not a specific medication. At the time, Forbes reported that, though the device showed great potential for revolutionizing how medications are managed by physicians, there was no way to know how individual medications would interact with the sensor, and the technology would have to jump through many more regulatory hoops before it would be available on the market. After the sensor’s initial approval, George Savage, co-founder and chief medical officer of Proteus, told Forbes that the company was in talks with pharmaceutical companies to potentially incorporate the sensor into medications for tuberculosis, diabetes, and other chronic conditions. If the FDA approves the digital medication, physicians will be able to decide whether or not they wish to prescribe Abilify with the sensors attached, and each prescription would require the full knowledge and consent of the patient, who could decide how much, if any, information could be transmitted back to their doctor. (Source: Med Device Online, 09/11/15)
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