Physician’s Seal, LLC®, innovators of REMfresh® (CRA-melatonin™), a clinically studied, drug-free, nonprescription, #1 sleep doctor-recommended melatonin sleep brand today announced significant, real-world data from a large group (1,116 patients) that supports and reinforces the benefits of REMfresh, the first and only continuous release and absorption melatonin (CRA-melatonin) formulation, which is designed to give patients up to 7 hours of sleep support. 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.

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