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FDA Reviewing New Drug Application for First Digital Pill

September 14, 2015
by Heather Landi
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Proteus Digital Health, based in Redwood City, Calif., is seeking Food and Drug Administration (FDA) approval for a new digital medicine, a pill embedded with an ingestible sensor that can monitor when a medication is actually taken.

Working with Tokyo-based Otsuka Pharmaceutical Co., Ltd., Proteus is pursuing a regulatory filing with the FDA for the drug-device which combines Abilify, a depression and schizophrenia medication, with the Proteus ingestible sensor in a single tablet.

According to a statement from both companies, this is the first time an FDA-approved medication, Abilify, has been combined and submitted for approval with a sensor within the medication tablet to measure actual medication-taking patterns and physiologic response. The sensor digitally records ingestion, and with patient consent, shares that information with healthcare providers and caregivers.

According to a study by the World Health Organization (WHO), approximately 50 percent of patients with chronic diseases in developed countries do not take medicines as prescribed, possibly limiting the effectiveness of those medicines. In the U.S., this lack of adherence may result in an estimated $100 to $300 billion in avoidable healthcare costs due to direct costs such as unnecessary escalation of treatment as well as indirect costs, the study reported.

“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,” William Carson, M.D., president and CEO of Otsuka Pharmaceutical Development & Commercialization, Inc. said in a statement. “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 New Drug Application (NDA) review.”

The Abilify tablet contains an ingestible sensor that communicates with a wearable sensor patch and a medical software application for measuring adherence in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorder in adults.

If approved by the FDA, healthcare professionals will have the ability to prescribe Abilify tablets with the Proteus ingestible sensor embedded in the tablet. According to Proteus, the product is filed as an NDA, and the FDA Center for Devices and Radiological Health (CDRH)-cleared ingestible sensor from Proteus will be embedded at the point of manufacture with the FDA Center for Drug Evaluation and Research (CDER)-approved Abilify as a combination drug-device, communicating with the Proteus patch and associated medical software.

“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,” Andrew Thompson, president and CEO of Proteus Digital Health said in a statement. “This means that medicines could be tailored to each of us to reflect our unique medication-taking patterns, lifestyle and daily health choices.”

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