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Proteus Digital Health And Otsuka Seek FDA Approval For World's First Digital Pill

September 14, 2015


When a healthcare provider writes a prescription for a medication, there is really no sure-fire way to confirm whether a patient is actually taking the medication as prescribed. Short of a patient recording the event in a regular journal or perhaps video journal, having an eyewitness or by monitoring specific physiologic parameters, compliance with medication is largely taken on faith.


While remote caregiving technology is presently available with sensors which can monitor when a pill bottle has been opened via companies such as BeClose, there is no guarantee that the patient actually swallowed the medication.


In developed countries, it is believed that up to 50% of patients with chronic diseases are noncompliant with medications they are prescribed, decreasing the efficacy of the medications themselves, and increasing risk of complications from the diseases.


In fact, a recent analysis in 2014 estimated that medical noncompliance adds between $100-$300 billion annually in healthcare costs. Ensuring compliance for patients with chronic diseases such as hypertension, diabetes, and mental illness could lead to enormous cost savings to the healthcare system.


The continued problem of medication adherence or compliance may be changing, however, as California-based Proteus DigitalHealth and Otsuka Pharmaceuticals have created the world’s first smart pill with an ingestible sensor linked to a wearable patch that can record when a pill is actually taken.


Proteus Digital Health reported on September 9 that the FDA will be reviewing its unique “chip within a pill” device for the depression and schizophrenia medication, Abilify, to hopefully gain approval as the worlds first digital medication.


“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,” said Wiliam H. Carson, M.D, President and CEO of Otsuka Pharmaceutical Development and Commercialization, Inc. “We believe this new digital medicine could revolutionize the way adherence is measured and fulfill a serious unmet medical need in this population. We look forward to continuing working with the FDA throughout the NDA review.”


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