David C. Brodner, M.D. Founder and Principle Physician The Center for Sinus, Allergy, and Sleep Wellness Double Board-Certified in Otolaryngology (Head and Neck Surgery) and Sleep Medicine Assistant Clinical Professor, Florida Atlantic University College of Medicine Medical Director, Good Samaritan Hospital Sleep Laboratory Senior Medical Advisor, Physician’s Seal, LLC®

REMfresh Study of Continuous Release Melatonin Demonstrated Improved Sleep Duration and Quality

MedicalResearch.com Interview with:

David C. Brodner, M.D. Founder and Principle Physician The Center for Sinus, Allergy, and Sleep Wellness Double Board-Certified in Otolaryngology (Head and Neck Surgery) and Sleep Medicine Assistant Clinical Professor, Florida Atlantic University College of Medicine Medical Director, Good Samaritan Hospital Sleep Laboratory Senior Medical Advisor, Physician’s Seal, LLC®

Dr. Brodner

David C. Brodner, M.D.
Founder and Principle Physician
The Center for Sinus, Allergy, and Sleep Wellness
Double Board-Certified in Otolaryngology (Head and Neck Surgery)
and Sleep Medicine
Assistant Clinical Professor
Florida Atlantic University College of Medicine
Medical Director, Good Samaritan Hospital Sleep Laboratory
Senior Medical Advisor, Physician’s Seal, LLC®


MedicalResearch.com: What is the background for this study?

Response: Chronic disorders of sleep and wakefulness affect an estimated 50-70 million adults in the United States. The cumulative long-term effects of sleep loss have been associated with a wide range of damaging health consequences, including obesity, diabetes, impaired glucose tolerance, cardiovascular disease, hypertension, anxiety and depression. In terms of preventing health consequences, sleeping 6-8 hours per night consistently may provide optimal health outcomes.

Comprehensive data from two recently completed patient-reported outcomes (PRO) studies provide further evidence of the observed hypnotic effects of REMfresh, demonstrating statistically significant improvements in sleep onset, sleep duration, sleep maintenance and sleep quality. PRO studies of this kind, which more closely address real-world patient experience, are increasingly being recognized by regulatory authorities and academia in evaluating new therapies. 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.

REMfresh, the first and only continuous release and absorption melatonin (CRA-melatonin) formulation, is designed to give patients up to 7 hours of sleep support. It is a clinically studied, drug-free, nonprescription, #1 sleep doctor-recommended melatonin sleep brand.

MedicalResearch.com: What are the main findings? 

Response: Our research demonstrated that the REMfresh Duration Validation (REMVAL) study provides further evidence of a correlative relationship between the 7-hour pharmacokinetic profile observed in the earlier clinical study, REM Absorption Kinetics Trial (REMAKT), and the hypnotic effects of REMfresh, observed in subsequent studies, as demonstrated by improvements in sleep onset, sleep duration, sleep maintenance, sleep quality and patient satisfaction. This latest study further validates the findings of past studies that have been presented and undergone peer review at major sleep conferences:

  • REMfresh Patient Reported Outcomes DURation (REMDUR), the first, 500-patient, PRO study of this sleep brand, presented at the annual meeting for sleep specialists, SLEEP 2018, which demonstrated that more than 77 percent of patients achieved 6 or more hours of sleep compared to 23.6 percent who slept that duration prior to taking REMfresh (p<.0001)2, and
  • REMAbsorption Kinetics Trial (REMAKT), a pharmacokinetic study presented at SLEEP 2017 and 2018, which demonstrated that REMfresh mimics the body’s own seven-hour Mesa-Wave® release profile, a natural pattern of melatonin blood levels during a normal night’s sleep cycle.

An additional PRO subset study, part of REMVAL, called the REMfresh Short Sleep Cohort Assessment (REMSS), assessed improvements in sleep duration and sleep maintenance among 311 patients with morbid or extreme short sleep duration of 4 hours or less.

These two PRO studies (REMVAL and REMSS) were presented at SLEEP 2019, the 33rd Annual Meeting of the Associated Professional Sleep Societies (APSS), which is a joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society, held in San Antonio, Texas, from June 8-12.

MedicalResearch.com: What should readers take away from your report? 

Response: These latest findings provide further confirmation of the potential for nonprescription REMfresh to help address the public health issue of the cumulative effects of sleep loss. Based on a novel Ion Powered Pump® (IPP®) delivery system that provides a pharmacokinetic (PK) profile that more closely aligns with the body’s own natural sleep pattern, REMfresh has demonstrated once again promising results and high levels of satisfaction in a real-world population of patients who have had chronic difficulties sleeping, providing up to seven hours of sleep support.

REMVAL Study Describes Improvements in Sleep Duration and Sleep Quality
The poster entitled, “Observed Hypnotic Effects with a Continuous-Release Ion Powered Pump Melatonin Delivery System: Self-Reported Patient Outcomes Study Results Demonstrating Improvement in Sleep Duration and Quality,” reported findings provides further real-world evidence of a correlative relationship between the originally observed 7-hour pharmacokinetic profile in the REM Absorption Kinetics Trial (REMAKT) and the strong hypnotic effects of CRA-melatonin observed in subsequent studies and may offer a new low-dose, drug-free alternative to prescription hypnotics to treat chronic sleep disturbances.

The 1,116-patient REMVAL study was designed to obtain clinically relevant information about patients’ past usage of melatonin and non-melatonin sleep aids, sleep patterns prior to taking CRA-melatonin, sleep duration before and after taking CRA-melatonin, frequency of CRA-melatonin usage, improvement in sleep onset, sleep maintenance and sleep quality after taking CRA-melatonin, and overall satisfaction with CRA-melatonin.

In the study, patients with sleep disturbances in the general population received a sample of REMfresh from their physicians and were invited to complete a 13-question online survey. After taking REMfresh, the majority (78.8 percent) of patients achieved a sleep duration of greater than or equal to 6 hours (p<.0001). More than 91 percent of patients reported a major/moderate improvement in sleep onset, sleep maintenance and sleep quality (p<.0001). Of the 30.7 percent of patients (342 in total), who reported never having taken other brands of melatonin, 99.4 percent indicated they were likely or very likely to continue taking REMfresh for their sleep issues (p<.0001).

REMSS Study Shows Improvement in Patients with Chronic, Extreme Short Sleep
The poster entitled, “Improvement in Sleep Duration and Maintenance with Ion Powered Continuous Release and Absorption Melatonin in a Cohort of Patients with Chronic Short Sleep Duration: Results from a Patient-Reported Outcomes Study,” highlighted findings from the REMfresh Short Sleep Cohort Assessment (REMSS), involving a cohort of 311 patients from the REMVAL study who reported sleeping four hours or less nightly. This cohort analysis was designed to obtain clinically relevant information from these patients experiencing morbid short sleep disturbances, including sleep patterns and melatonin usage before taking REMfresh, sleep duration before and after taking REMfresh, improvement in sleep onset, sleep maintenance and sleep quality after taking REMfresh, and overall product satisfaction.

Data from this cohort show that 95.8 percent of patients who previously experienced daily, morbid short sleep duration of less than or equal to 4 hours reported an improvement in sleep duration (p<.0001), including more than 46 percent who achieved a sleep duration of greater than or equal to 6 hours (p<.0001). This increase from less than or equal to 4 hours to greater than or equal to 6 hours represents a major sleep duration upgrade in this group facing morbid sleep disturbances. More than 93 percent of patients reported a major/moderate improvement in sleep onset, sleep maintenance and sleep quality (p<.0001). Ninety-nine percent of the patients suffering with morbid short sleep (27.2 percent of whom had never previously tried a melatonin brand) reported that they were very likely or likely to continue using CRA-melatonin. These results provide real-world evidence that CRA-melatonin with its extended 7-hour pharmacokinetic plateau time and benign safety-profile may be a practical baseline therapy to improve sleep duration and other key sleep parameters, including, sleep maintenance and sleep quality in this group of patients who have a higher risk of all-cause mortality. 

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: Larger studies on the effect of REMfresh® (CRA-melatonin) in adults will add additional information to our body of knowledge. 

Any disclosures?

Disclosures: Dr. Brodner is Senior Medical Advisor to Physician’s Seal®, the company that markets REMfresh® (CRA-melatonin). Their web site is www.Remfresh.com for further information on the product or connect with them on Facebook and YouTube. 

Citations:

SLEEP 2019 Posters

  • (Abstract 0398, Poster Board #135) Improvement in Sleep Duration and Maintenance with Ion Powered Continuous Release and Absorption Melatonin in a Cohort of Patients with Chronic Short Sleep Duration: Results from a Patient-Reported Outcomes Study
  • (Abstract 0399, Poster Board #136) Observed Hypnotic Effects with a Continuous-Release Ion Powered Pump Melatonin Delivery System: Self-Reported Patient Outcomes Study Results Demonstrating Improvement in Sleep Duration and Quality

The abstracts are published in an online supplement of the journal, Sleep, which is available at https://sleepmeeting.org/wp-content/uploads/2019/04/SLEEP_42_S1-Website-Final.pdf. 

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Jun 23, 2019 @ 9:52 pm

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