FDA Accepts for Review First NDA for a 'Digital' Medicine

The US Food and Drug Administration (FDA) has accepted for review what is being considered the first new drug application (NDA) for a combination product to include a sensor embedded into the tablet.

The developer of the sensor – Proteus Digital Health – said it could help improve patient medication adherence and better inform physician decision-making to tailor treatments to the patient's needs.

In the case of this new drug application, the sensor is paired with Otsuka Pharmaceutical's FDA-approved Abilify (aripiprazole). The combo product includes the tablet, which 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.

Back in 2012, FDA cleared Proteus' ingestible device, which was in development since 2008, via the de novo clearance pathway, which is used for low-risk devices.

When ingested, the sensor sends a signal to the wearable patch after it reaches the stomach. The patch then records and time-stamps the information from the ingestible sensor in addition to collecting other 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 a physician or other caregiver.

Patients can view the information via the software application on their mobile phone or device while physicians or caregivers can view the data using secure web portals.

The companies say this is the first time an FDA-approved medication has been combined and submitted for approval with a sensor within the tablet to measure medication-taking patterns and physiologic response.

Dr. William Carson, president and CEO of Otsuka, 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 NDA review."

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