Ingestible sensor offers promise for medication adherence

The digital medicine revolution received a small but significant boost earlier this month when the FDA accepted a claim by Proteus Digital Health (Redwood City, CA) that its ingestible sensor technology can measure medication adherence. As a result, the device’s Indications for Use can now include medication adherence.

The device, which was first approved by the FDA in 2012, integrates pharmaceuticals with both an ingestible and wearable sensor to determine actual intake time of the drug. A smartphone app records the information and can transmit it to users, including healthcare providers, family members and other caretakers.

Currently, Proteus is partnering with Otsuka Pharmaceutical to launch a digital antipsychotic and with Novartis in an organ-transplantation application. Earlier this year, Proteus announced a partnership with Oracle Health Sciences on a medication adherence platform for use in clinical trials. Markus Christen, PhD, head of global development for Proteus, says the first clinical trial to use this platform is set to begin later this year.

In addition to carrying out these partnerships, Proteus is developing its own portfolio of fully integrated digital drugs to help improve adherence in the areas of cardiovascular and metabolic diseases. Christen expects these to be available over the next few years.

“Pharma companies have their own way of doing things, and we believe a different approach is necessary for marketing and positioning drugs for better patient outcomes,” he says. “We want to explore these routes ourselves and be at the forefront of where healthcare is changing.”

As for cost, Christen says it will depend on volume, as well as the benefit provided by increased adherence. “At a high volume and with the right benefit to the healthcare system, I’m quite confident we’ll have an excellent cost-benefit situation.”