eTect Announces Initiation of a Clinical Study Using Its Novel Ingestion Event Monitoring System to Reliably Track Opioid Use for Pain Management

| January 26, 2016 | 0 Comments

NEWBERRY, FLORIDA – January 26, 2016 – eTect, Inc., a healthcare technology company developing medication adherence solutions for use in clinical research and healthcare, today announced it has initiated a clinical trial using its ID-Cap System to better understand how pain medicine is used by patients. The study is being conducted in collaboration with clinical researchers at the University of Massachusetts Medical School. The study will enroll 30 patients who have been discharged from the Emergency Department following a fracture of the arm or leg and who have been prescribed oxycodone for the management of their pain.

The ID-Cap System is a novel technology that provides confirmation of medication ingestion and reports when medication doses are taken in real time. The ID-Cap System consists of an ingestible microsensor that is embedded in an oral dosage form that, when activated by stomach fluid, transmits digital messages to an external wearable reader to confirm ingestion. Connected devices have become a significant part of daily life, and the ID-Cap System provides a unique platform to connect medicine digitally within the healthcare ecosystem. It will populate clinical research databases and electronic medical records with medication adherence data that researchers and healthcare professionals can rely upon for better decisions, increased value of therapeutic interventions, and improved patient outcomes.

The ID-Cap technology enables new insights into how and when medications are taken, which is particularly important when opioid medications, such as oxycodone, are prescribed. Opioids are one of the most important and widely used classes of medication for managing chronic pain, but carry risks associated with their potential for addiction, abuse, misuse, and adverse effects. Opioids are a top public health concern as recognized by the United States Centers for Disease Control and Prevention (CDC). When used improperly or by patients who should not receive them, they can cause serious harm, including overdose and death.

This clinical study will contribute to the body of knowledge regarding opioid medication utilization and expand the evidence in support of the ID-Cap System. In this study, a new form factor for the external reader that detects the signals from each ingested capsule in the stomach will be evaluated. Due to the high potential for adverse events with an adhesive patch and patient preferences regarding the wearable reader, eTect has developed a reader that does not require direct attachment to the skin, providing adherence without adhesion. eTect’s proprietary communication technology uniquely enables the reader to be off the body, allowing flexibility in the design of patient-friendly readers with high performance and convenience to the patient.

“The use of eTect’s ID-Cap System in its first clinical study to track and report on the use of opioid medications is an important milestone for patients and healthcare professionals who care for them,” said Edward W. Boyer, M.D., Ph.D., Professor of Emergency Medicine and Chief of the Division of Medical Toxicology at the University of Massachusetts Medical School and Principal Investigator of the study. “Our hope is that by better understanding the medication-taking behavior of patients, we can provide better pain relief and make the best decisions regarding the care of our patients. As we strive to ensure appropriate use of medicine, including opioid therapy, insight into how patients actually use the medicine we prescribe is critical to our evaluation of these therapies and achievement of desired patient outcomes.”

A separate clinical study is currently being conducted at the Medical University of South Carolina in support of the clinical validation of the ID-Cap System. This study has been designed to evaluate use of the ID-Cap System in monitoring and improving medication adherence. Additional clinical validation studies in partnership with pharmaceutical companies, the NIH, and academic research organizations are planned for 2016.

eTect’s technology enables an objective measurement of medication ingestion with real-time reporting of time-stamped dose ingestion events, ensuring that this important information is available to doctors who need it to provide the best care to their patients. The ID-Cap System allows a definitive understanding of medication-taking behavior that has the potential to transform how medications are evaluated by clinical researchers, prescribed by doctors, and used by patients.

Medication Adherence
Nonadherence to prescribed medications is an important consideration in the clinical management of patients and in clinical research and drug development. Considerable research has been conducted to elucidate the reasons for nonadherence, which are often unique to the individual patient and the specific medication of interest. Across different disease states and medications, nonadherence directly impacts drug exposure and therapeutic outcomes. An estimated 50% of patients in developed countries are not adherent to prescribed medications for chronic health conditions, and the magnitude and impact of the problem are even greater in developing countries. Poor adherence is associated with increased healthcare costs and contributes over $100 billion in avoidable medical costs in just the United States alone. The accurate detection and reporting of medication nonadherence are critical for healthcare providers, payers, and clinical researchers to evaluate and optimize therapeutic interventions. Current methods that are commonly used for monitoring medication adherence, such as patient self-reports, pill counts, and prescription refill histories, comprise indirect measures that are generally incomplete and inaccurate and cannot be effectively utilized for understanding and tracking actual medication use. Reliable methods for objectively measuring medication adherence behaviors that can be easily implemented for remote health monitoring are needed.

About eTect
eTect, Inc. (www.etectbio.com), an early-stage healthcare technology company, is the creator of the ID-Cap System, a patented, cost-effective platform that uses ingestible sensors to measure medication adherence for the pharmaceutical and mobile health (mHealth) industries. By providing a verified record of adherence that can be easily linked to mHealth systems, ID-Cap improves medication use and treatment outcomes for many patient populations, including those who are on high-cost/high consequence specialty drugs or complex drug regimens and those who are difficult to treat. ID-Cap also revolutionizes clinical trials, reducing both cost and time to market while enhancing clinical trial outcomes.

For more information, please visit www.etectbio.com.

Contact:
Eric Buffkin, President, eTect, Inc.
352.262.8947
eric@etectbio.com

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