Proteus, Otsuka submit first commercial drug with built-in sensor to FDA

By Jonah Comstock

ProteusAfter years of using its digital health feedback system in clinical trials and studies, Proteus Digital Health, and partner Otsuka Pharmaceuticals, are poised to launch the first mass market drug to incorporate Proteus's ingestible sensor. The companies have submitted a sensor-embedded version of the antidepressant Abilify for FDA approval.

“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,” Dr. William H. Carson, president and CEO of Otsuka Pharmaceutical Development and Commercialization, 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 [new drug application] review.”

The new drug-sensor combination will operate very similarly to Proteus's already cleared Digital Health Feedback system with one notable difference: the ingestible sensor will be embedded in the same tablet as the drug. Combined with a second sensor in an adhesive patch, it will measure medication-taking patterns and physiological responses, and will send that data (with the patient's permission) to the patient's care provider, as well as displaying it on the patient's smartphone. 

Abilify is prescribed to patients with depression, schizophrenia, or bipolar disorder. Behavioral health makes sense as a starting point for Proteus in moving its technology into actual patient use, since conditions that affect a patient's behavior often go hand-in-hand with patients not taking their medications -- and not necessarily telling anyone they've stopped. The Proteus system could allow doctors to get an early warning when a patient goes off his or her meds, potentially preventing a manic or schizophrenic episode.

The combined pill has been submitted as a new drug application (NDA), rather than as a medical device. But both Abilify and the Proteus Digital Health feedback system are already FDA approved and cleared, respectively. In fact, Proteus's clearance was updated this summer to allow Proteus to claim and market its product’s ability to quantify medication adherence, something the company believes is unprecedented.

Proteus and Otsuka have likely been working on this for three years. When the two first announced their partnership in 2012, the companies said in a press release the had a "collaboration to develop commercial products in two defined therapeutic areas of high unmet medical need." If approved, this drug would be the first commercial product to come out of the partnership.