The companies said the FDA accepted their new drug application for the drug-device combination, using the Proteus ingestible sensor and Otsuka’s aripiprazole drug in patients with serious mental illnesses such as major depressive disorder, bipolar disorder and schizophrenia. It’s the 1st time the federal safety watchdog has reviewed a drug-device combo designed to measure adherence.
The Proteus pill is designed to signal a wearable patch after it reaches the stomach, recording and time-stamping data from the pill and other patient metrics. The data can be relayed via Bluetooth to mobile devices and, with consent, to healthcare providers.
“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,” Proteus president & CEO Andrew Thompson said in prepared remarks. “This means that medicines could be tailored to each of us to reflect our unique medication-taking patterns, lifestyle and daily health choices.”
“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,” added Otsuka president & CEO Dr. William Carson. “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.”