The “Beyond the Pill” movement marked a major milestone with the FDA’s acceptance of the first digital medicine-New Drug Application. It will pair Proteus Digital Health’s ingestible sensor platform with Otsuka Pharmaceuticals’ FDA-approved Abilify drug to treat people with schizophrenia, bipolar disorder and in some cases for major depressive disorder to monitor adherence.
The Abilify tablet contains an ingestible sensor that communicates with a wearable sensor patch and medical software application. The idea is to measure adherence.
Otsuka CEO for development and commercialization Dr. William Carson said in a statement that 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.
The technology behind the embedded sensor is pretty cool. Stomach juices activate an energy source — similar to a potato starch battery. The embedded sensor sends signals to a skin patch electrode, which wirelessly transmits information such as vital signs, body position and verification of medication ingestion.
The sensor would be embedded during the drug manufacturing process as a combination drug-device, communicating with the Proteus patch and relevant medical software. If approved, the combination drug-device could be used to tailor medicines more closely to reflect each of our medication-taking patterns and lifestyle choices, Andrew Thompson, Proteus Digital Health CEO said in a statement.
The complexities behind poor adherence loom large in the face of attempts to improve it. But with schizophrenia the consequences of non adherence include relapse, hospitalization and attempted suicide, depending on the severity of the condition.
Last year Proteus Digital Health raised $120 million to commercialize its digital medicines.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The FDA’s move follows its clearance of Propeller Health’s remote monitoring platforms for GSK and Boehringer Ingelheim to better track how people with asthma and COPD use their inhalers between appointments. The idea is that by tracking how patients use the devices Propeller’s platform can provide useful information to physicians to help alert them to potential problems with patients’ medication or the inhaler, before the problems worsen.
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