Startup submits novel biomarker for clinical trial medication adherence tracking to FDA

XhaleSmart Medication Adherence Monitoring system--Courtesy of Xhale

Proteus Digital Health and Otsuka submitted the first medication to incorporate adherence technology to the U.S. Food and Drug Administration for approval last week. Now, startup Xhale has submitted the first biomarker for medication adherence monitoring to the regulatory agency. Proteus obtained an FDA nod specifically for its medication adherence technology in July.

The Xhale submission is for its Smart Medication Adherence Monitoring system--which works by incorporating an adherence marker within a medication capsule. In minutes after the medication is taken, the maker is metabolized. The user then blows into the Smart device to enable detection of a metabolite of the marker on their breath.

The technology is intended, at least at first, for use in clinical testing to ensure trial participant medication compliance. It's specifically been designed for that purpose. This FDA submission is for the full Biomarker Qualification package and follows the agency's review of earlier, initial briefing packages, Xhale said.

How the Smart system works--Courtesy of Xhale

"One of the qualities that makes Smart particularly unique is that it provides a definitive assessment of medication adherence," said Dr. Donn Dennis, a co-inventor from the University of Florida and co-founder of Xhale, in a statement. "In other words, because the Smart device measures the metabolite created in the patient's body and provides a key biometric parameter--the facial photograph--we know definitively that the medication was swallowed by the intended individual."

He continued, "It's simple, elegant and definitive. Having a high degree of confidence in the quality of adherence data is a very important consideration in the assessment of clinical trial safety and efficacy data by pharmaceutical companies and regulatory authorities."

Unlike the Proteus system that relies upon an ingestible chip, Xhale's Smart system is a food-grade, digestible marker that doesn't require an accompanying adhesive skin patch for monitoring.

Xhale was founded in 2005 and its research has been backed by the National Institutes of Health (NIH). The company also markets a disposable nasal pulse oximetry sensor and monitor that tracks heart rate and blood oxygenation that was cleared by FDA in April 2013.

- here is the announcement