Last September, the Medical Device industry saw the FDA accept the first New Drug Application (NDA) for digital medicine which, in this case, treats patients with mental illness. The new application embeds an ingestible sensor from Proteus Digital Health into Otsuka’s ABILIFY (aripiprazole) tablet which transmits information to wearable Proteus patch after entering the stomach. Besides recording and time-stamping information communicated by the sensor, the patch collects other patient data such as rest, body angle and activity to measure physiologic response.
Using a mobile phone or Bluetooth-enabled device to receive the data, patients can opt to share it with their clinicians and caregivers who access it through secure portals. This gives medical personnel the opportunity to measure how well patients with schizophrenia and bipolar disorder associated events adhere to their aripiprazole treatment regimen. In addition, it lets doctors know if patients go off their medication which leads to disease relapse requiring costly treatment. In the U.S., non-compliance with prescribed medicine, costs an estimated $100-$300 billion per year in direct and indirect costs.
Digital medical devices such as the continuous glucose monitor and devices to monitor vital signs became possible with high-level miniaturized electronic systems coupled with improved wireless technology. With real-time feedback, these devices provide clinicians with data that can help establish the patient’s disease allowing clinicians to tailor treatment to patient needs.
The companies filed their application as an NDA where they embed the Proteus sensor, cleared by the FDA Center for Devices and Radiological Health (CDRH), with the FDA approved ABILIFY tablet as a combination drug-device communicating with the Proteus patch and associated software.
If the FDA approves the NDA, company officials believe their device will give patients a new option for managing symptoms and sharing personally unique information with their health care team.
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