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FDA Accepts New Drug Application for Abilify Embedded with Digital Sensor

NDA is an early opportunity to demonstrate the potential of digital medicines

The FDA has accepted the filing of a new drug application (NDA) for the combination product of aripiprazole (Abilify, Otsuka) embedded with a Proteus ingestible sensor in a single tablet, Otsuka and Proteus Digital Health announced.

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 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 U.S., this may result in an estimated $100 billion to 300 billion in avoidable health care costs due to direct expenses 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.

If the product is approved by the FDA, health care 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 health care professional to measure medication adherence and other patient metrics. The ingestible sensor from Proteus, cleared by the FDA Center for Devices and Radiological Health, would be embedded at the point of manufacture with Abilify, approved by the FDA Center for Drug Evaluation and Research, creating a combination drug-device.

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, with their consent, to their physician and/or 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.

Source: Otsuka; September 11, 2015.

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