Scientifically Advanced Delivery Technology in Sleep Management Debuts at SLEEP 2017 with Clinical Data Showing REMfresh®, the First and Only Continuous Release and Absorption Melatonin, Helps Maintain Sleep for up to 7 Hours
PRNewswire: June 5, 2017 – BOSTON, MA, U.S.A. – Landmark clinical data presented today highlight a scientific breakthrough in the management of sleep with a drug-free, non-prescription sleep product, REMfresh® , the first and only, continuous release and absorption melatonin (CRA-melatonin) to mimic the body’s own 7-hour Mesa Wave™, a natural pattern of melatonin blood levels during a normal night’s sleep cycle. The study demonstrated the continuous release and absorption of 99% ultra-pure melatonin in REMfresh® (CRA-melatonin) was designed to induce sleep onset and provide continuous, lasting restorative sleep over 7 hours. The scientifically advanced, patented formulation, called Ion Powered Pump (IPP™) technology, replicates the way in which the body naturally releases and absorbs melatonin, unlike conventional melatonin sleep products. Since REMfresh® is not a drug, there is no drug hangover.
The data are being presented in three posters on Sunday, June 4, and Tuesday, June 6, during SLEEP 2017, the 31st Annual Meeting of the Associated Professional Sleep Societies LLC (APSS). The meeting is a joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).
“These results represent an unparalleled breakthrough in drug-free sleep maintenance therapy that physicians and their patients have been waiting for,” said David C. Brodner, M.D., a leading sleep specialist who is double board-certified in otolaryngology–head and neck surgery and sleep medicine, founder and principal physician at the Center for Sinus, Allergy, and Sleep Wellness, in Palm Beach Country, Florida, and senior medical advisor for Physician’s Seal, LLC® . “Melatonin products have been used primarily as a chronobiotic to address sleep disorders associated with abnormal timing of the circadian system, such as jet lag and shift work, but that has now changed. With its patented 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.”
The findings are based on REMAKT™ (REM Absorption Kinetics Trial), a U.S.-based randomized, crossover pharmacokinetic (PK) evaluation study in healthy, non-smoking adults that compared REMfresh® (CRA-melatonin) with a market-leading, immediaterelease melatonin (IR-melatonin). The study found that melatonin levels with REMfresh® exceeded the targeted sleep maintenance threshold for a median of 6.7 hours, compared with 3.7 hours with the leading IR-melatonin. Conversely, the levels of the marketleading IR-melatonin formulation dramatically increased 23 times greater than the targeted levels of exogenous melatonin for sleep maintenance and had a rapid decline in serum levels that did not allow melatonin levels to be maintained beyond 4 hours.
Analysis presented at SLEEP 2017 showed that REMfresh® (CRA-melatonin) builds upon the body of evidence from prolongedrelease melatonin (PR-M), which demonstrated in well-conducted, placebo-controlled studies, statistically significant improvement in sleep quality, morning alertness, sleep latency, and quality of life in patients aged 55 years and older compared with placebo. REMfresh® (CRA-melatonin) was designed to overcome the challenges of absorption in the intestines, thereby extending the continual and gradual release pattern of melatonin through the night (known as the Mesa Wave™, a flat-topped hill with steep sides). There was a faster time to Cmax, which is anticipated to result in improved sleep onset, while the extended median plateau time to 6.7 hours and rapid fall-off in plasma levels at the end of the Mesa Wave™ may help to improve sleep maintenance and morning alertness.
Chronic sleep and wakefulness disorders affect an estimated 50 to 70 million Americans, and long-term sleep deprivation has been associated with negative health consequences, including an increased risk of diabetes, hypertension, heart attack, stroke, obesity, and depression.
Sleep/wake cycles are regulated by melatonin, levels of which normally begin to rise in the mid- to late evening and remain high for the majority of the night. Levels begin to decline towards early morning, as the body’s wake cycle in triggered. Melatonin levels typically decline with age, with a significant decrease after age 40.
The REMAKT™ data will be submitted for peer review and publication in a medical journal.
Physician’s Seal® is the innovator of REMfresh® , the first and only continuous release and absorption, 99% ultra-pure melatonin (CRA-melatonin) that mimics the way the body naturally releases and maintains melatonin over a 7-hour period. Physician’s Seal® , founded in 2015, is a privately held company based in Boca Raton, Florida. It is committed to bringing cutting-edge life science applications to doctors and their patients. For more information, visit www.remfresh.com.
