FDA Accepts First Digital Medicine New Drug Application

Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health recently announced the US FDA has determined that the New Drug Application for the combination product of ABILIFY (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet is sufficiently complete to allow for a substantive review and is considered filed as of September 8, 2015.

This is the first time an FDA-approved medication (ABILIFY) has been combined and submitted for approval with a sensor within the medication tablet (the Proteus ingestible sensor) to measure actual medication-taking patterns and physiologic response. This objective information is communicated to the patient – and with the consent of the patient – to the patient’s physician and/or caregiver. Digital Medicines may enable improved patient medication adherence and better informed physician decision-making to tailor treatment to the patient’s needs.

An estimated average of 50% of patients with chronic diseases in developed countries do not take medicines as prescribed, possibly limiting the effectiveness of those medicines. In the US, this 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. For example, patients suffering from chronic mental disorders, such as schizophrenia, are often required to take medication for long periods, and it is not unusual for these patients to discontinue taking their medication, or not take their medication as prescribed, which can lead to disease relapse and recurrence.

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.

“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 William H. Carson, MD, President and CEO of Otsuka Pharmaceutical Development & 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.”

If approved by the FDA, healthcare professionals will have the ability to prescribe ABILIFY tablets with the Proteus ingestible sensor embedded in the tablet. This drug-device product can provide the patient with a treatment option to help manage symptoms while allowing the caregiver and healthcare professional to measure medication adherence and other patient metrics. This unique system is filed as an NDA, where 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,” said Andrew Thompson, President and CEO of Proteus Digital Health. “This means that medicines could be tailored to each of us to reflect our unique medication-taking patterns, lifestyle, and daily health choices.”

When ABILIFY with the embedded ingestible sensor is taken, the ingestible sensor sends a signal to the wearable Proteus patch after it reaches the stomach. The patch records and time-stamps the information from the ingestible sensor in addition to collecting other patient metrics, including rest, body angle, and activity patterns. This information is recorded and relayed to patients on a mobile phone or other Bluetooth-enabled device, and only with their consent, to their physician and/or their caregivers. Patients view the information using a secure and local software application on their mobile phone or device. Physicians and caregivers view the data using secure web portals. For more information, visit www.proteus.com.