Xhale submits Biomarker Qualification package to FDA for Medication Adherence Monitoring Tool.
Gainesville, FL, September 21, 2015
Xhale, Inc. announced today that it has submitted to the Food and Drug Administration (FDA) the first Biomarker Qualification package for a Drug Development Tool for medication adherence monitoring.
The submittal to FDA marks an important step for the company’s patented SMART® Medication Adherence Monitoring system. The components of the system are a breath-based SMART® device and an adherence marker which is incorporated into a capsule with the medication. Within minutes after the medication is swallowed, the adherence marker is absorbed in the stomach and metabolized. The study participant then blows into the SMART® device, which takes a photo of the person’s face as they are providing the breath sample, and a metabolite of the marker is detected in the breath, proving that the medication was ingested by a specific individual. The SMART® device wirelessly transmits that information to cloud servers in real-time via a built in cellular connection.
SMART® is the culmination of more than 6 years of development, including support from the National Institutes of Health in funding the development of the system. The underlying technology was licensed from the University of Florida (UF), one of the nation’s premiere public research universities and an academic leader in technology transfer.
“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 UF and co-founder of Xhale. “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. 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.”
The full Biomarker Qualification package was submitted to FDA based on their invitation after the agency had reviewed data and information on the SMART® system from earlier initial briefing packages.
Xhale has designed the SMART® system for use in pharmaceutical clinical trials. Pharmaceutical companies often spend more than $1 billion to obtain marketing approval for a new medication. “According to industry reports,” explained Richard R Allen, CEO of Xhale, “average nonadherence rates among patients in clinical trials receiving treatment for chronic conditions can be as high as 57%*. If a drug fails to achieve approval in part because participants aren’t taking the study medication, not only is it a terrible waste of money, but drugs that could be helpful to patients may never gain approval.”
Unlike systems that rely on ingestible chips, with SMART® the patient is only ingesting a food-grade marker with the medication, and no adhesive skin patch is required for monitoring. Furthermore, because SMART® includes metabolite detection in the breath and a photo of the person providing the breath sample, with SMART® there is no question who ingested the medication.
Contingent upon qualification, FDA plans to publish the qualification recommendation as an appendix to their guidance on the FDA Guidances (Drugs) website.
Xhale, Inc. is a medical technology company commercializing novel monitoring platforms for the healthcare industry. Through its subsidiary Xhale Smart, Inc. the company is commercializing it’s breath-based medication adherence monitoring system called SMART®. Through its subsidiary Xhale Assurance, Inc., Xhale is commercializing the Assurance® pulse oximetry sensor, a simple, highly-effective single-point-of-contact sensor that can reliably monitor critical cardiorespiratory parameters under challenging conditions for patients. Xhale was founded on technology licensed from the University of Florida. For more information, please visit www.xhale.com or contact the company at email@example.com.
*The New England Journal of Medicine in 2005 (Lars Osterberg, M.D. and Terrence Blaschke, M.D., “Drug Therapy: Adherence to Medication”)