News Feature | September 11, 2015

FDA Agrees To Consider First Digital Medication Application

By Suzanne Hodsden


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.

Fast forward three years, and the first completed digital medication to cross the developmental finish line is a digital version of Otsuka’s Abilify, a drug indicated for the treatment of severe depression, bipolar disorder, and schizophrenia.  William Carson, CEO of Otsuka Pharmaceutical Development and Commercialization, believes that mental health medications are ideally suited for digital integration and that their use will address a serious unmet need of mentally ill patients.

“Today, patients suffering from severe mental illnesses struggle with adhering to or communicating with their healthcare teams about their medication regimen, which can greatly impact outcomes and disease progression,” Carson said in a press release

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.

In the press release, Andrew Thompson, CEO of Proteus, said that digital medication will usher in a new era in which a patient’s treatment can be closely monitored and tailored to suit their individual needs.

“Digital medicines have the potential to move healthcare beyond the proven efficacy of a medicine to understand the real world effectiveness of a therapy for each individual,” said Thompson.

In a study published last year in Risk Management and Healthcare Policy, authors noted that between 25 and 50 percent of patients failed to adhere to their prescribed drug regimen, and billions of dollars are spent each year on re-hospitalizations, urgent care visits, and co-morbid conditions that develop as a result of non-adherence.