Physician’s Seal, LLC®, innovators of REMfresh® (CRA-melatonin™), a clinically studied, drug-free, nonprescription sleep brand, today announced the data analysis plans for two significant patient- reported outcomes (PRO) studies related to the use of REMfresh® to treat occasional sleeplessness. REMfresh is the first and only continuous release and absorption melatonin (CRA-melatonin) formulation to give patients up to 7 hours of sleep support.
It is anticipated that these two PRO studies will provide validation of a correlative relationship between REMfresh’s 7-hour Mesa-Wave pharmacokinetic (PK) profile and real-world evidence of improvement in sleep quality. PRO studies are being used more regularly by regulatory authorities and academia to provide real-world patient experiences in assessing a new technology or therapy.
The first ongoing study, REMfresh Duration VALidation (REMVAL), is designed to assess improvement in sleep duration, onset, maintenance, quality and patient satisfaction in a general patient population. The second ongoing study, REMfresh Short Sleep Cohort Assessment (REMSS), a cohort analysis of patients suffering with chronic short sleep duration (< 4 hours of sleep nightly), is designed to assess improvement in sleep duration and maintenance. The initial phase of these studies has reached the appropriate patient participation thresholds. Statistics & Data Corporation, a top-tier clinical data services provider, has independently determined that the number of participants in the study provides adequate power (>90%) to detect even small improvements in sleep outcomes. This high power, or probability of seeing statistically significant results if CRA-melatonin is truly working to improve sleep outcomes, applies to the overall study population (REMVAL) as well as the cohort of short sleepers (REMSS). There will be an extended phase of recruitment to be completed no later than May 1, with all results to be peer-reviewed and presented at medical meetings later in 2019.
A previously peer-reviewed and presented pharmacokinetic (PK) evaluation study, REM Absorption Kinetics Trial (REMAKT), demonstrated REMfresh mimics the body’s own 7-hour Mesa-Wave® release profile, a natural pattern of melatonin blood levels during a normal night’s sleep cycle.
“Sleep research continues to be important because the cumulative effects of sleep loss are now becoming an important public health issue,” said David C. Brodner, M.D., a leading sleep specialist who is Double Board-Certified in Otolaryngology — Head and Neck Surgery as well as Sleep Medicine, Founder and Principle Physician at the Center for Sinus, Allergy, and Sleep Wellness, in Palm Beach County, Florida, and Senior Medical Advisor for Physician’s Seal, LLC.
Dr. Brodner continued, “Melatonin products have been used primarily as chronobiotics to address sleep disorders associated with abnormal timing of the circadian system, such as jet lag and shift work, but that is now fast changing. With its patented Ion Powered Pump® (IPP®) delivery system that mimics the body’s own natural sleep pattern, REMfresh may allow more individuals having trouble sleeping to experience drug-free, consistent, restorative sleep and have an improved quality of life with up to 7 hours of sleep support.”
“The clinical data on REMfresh, unveiled at the annual SLEEP medical meetings in 2017 and 2018, represented a significant advance in drug-free sleep maintenance therapy, an area of high unmet need,” said Dr. Brodner. “With the growing availability of nonprescription REMfresh nationwide, it is gratifying to see the remarkably strong patient satisfaction and “willingness to recommend” scores.
The results from these ongoing PRO studies are anticipated to provide further confirmatory real-world evidence of improvements in sleep duration and quality with the use of REMfresh.”
Value of Patient-Reported Outcomes Studies: Incorporate Patient Perspective
Increasingly, there is an appreciation by the U.S. Congress, regulatory authorities and academia, of the substantive value that real-world patient experience brings to assessing a new technology or therapy. In addition to the traditional randomized, placebo-controlled trial studies, regulatory authorities are now incorporating the patient perspective in their decision making, including PRO studies. A PRO study is a measurement based on a report that comes directly from the patient about the status or change in their health condition and without amendment or interpretation of the patient’s response by health-care intermediaries. PRO measures can be used to capture a patient’s everyday experience outside of the clinician’s office, and the effects of a treatment on the patient’s activities of daily living. Together, clinical measures and PRO measures can provide a fuller picture of patient benefit.