First-Ever Study Of 7-Hour, Drug-Free Continuous Release And Absorption Melatonin (CRA-melatonin™) REMfresh®, Published In Primary Care Companion For CNS Disorders Journal

MEMPHIS, Tenn. and BOCA RATON, Fla., Aug. 2, 2019 /PRNewswire/ -- Physician's Seal, LLC, today announced that Primary Care Companion for CNS Disorders, a peer-reviewed primary care medical journal, has published results of a U.S.-based randomized, crossover pharmacokinetic (PK) evaluation study in healthy, non-smoking adults, called REMAKT (REM Absorption Kinetics Trial), that compared REMfresh® continuous release and absorption melatonin (CRA-melatonin™) with a market-leading, immediate-release melatonin (IR-melatonin). The study results point to REMfresh as an important baseline option for sleep. This is the first time that researchers have observed melatonin blood levels that mimicked the body's own natural pattern of melatonin. This is enabled by the patented Ion-Powered Pump® (IPP®) technology in REMfresh. This breakthrough  technology allows melatonin to be continuously released and absorbed through the gastro-intestinal track for up to 7 hours.

The published study, entitled "A Randomized, Crossover, Pharmacokinetics Evaluation of a Novel Continuous Release and Absorption Melatonin Formulation," demonstrated that melatonin levels with REMfresh exceeded the targeted sleep maintenance threshold for a median of 6.7 hours, compared with 3.7 hours for IR-melatonin. Conversely, the levels of the IR-melatonin formulation dramatically increased 23 times greater than the targeted sleep maintenance threshold level, and then had a rapid decline in serum levels that did not allow melatonin levels to be maintained beyond 4 hours. 

The study is now available to the public on the journal website. Primary Care Companion for CNS Disorders, formerly The Primary Care Companion to The Journal of Clinical Psychiatry, is a web-based, peer-reviewed, abstracted publication that seeks to advance the clinical expertise of primary care physicians and other health care professionals who treat patients suffering from mental and neurological illnesses.

REMfresh, a clinically studied, drug-free, nonprescription #1 sleep doctor-recommended melatonin brand¹, is the first and only continuous release and absorption melatonin (CRA-melatonin) formulation designed to give patients up to 7 hours of sleep support.

"This study represents an important step forward in addressing the public health issue of the cumulative effects of sleep loss," said David J. Seiden, M.D., a recognized expert in the field of Sleep Medicine and Medical Director for the Baptist Health Sleep Centers of South Florida, Pembroke Pines, Florida. "In this study, REMfresh was shown to achieve quick release and then continuous release and absorption of melatonin for up to 7 hours, which, besides helping with sleep onset, may help to improve sleep maintenance and morning alertness. Most importantly, this study is an important advancement in the use of melatonin, not only as a chronobiotic, but potentially with drug-free hypnotic effects to initiate and maintain sleep." Dr. Seiden serves as a principal investigator for over 100 sleep disorder clinical trials and has published numerous manuscripts in peer-reviewed medical journals.

The 7-hour action of REMfresh has been validated by two real-world, patient-reported outcomes (PRO) studies, REMfresh^® Patient Reported Outcomes DURation (REMDUR)  and REMfresh Duration Validation (REMVAL). Both of these studies, involving a total of over 1,600 patients, have been peer reviewed, accepted and presented at SLEEP 2018 and SLEEP 2019, respectively, the Annual Meetings of the Associated Professional Sleep Societies (APSS), and a joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS). Both of these studies demonstrated significant user benefit in sleep onset, sleep duration and sleep quality when taking REMfresh.^2,3

Chronic disorders of sleep and wakefulness affect an estimated 50-70 million adults in the United States.⁴ 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.⁵ In terms of preventing health consequences, sleeping 6-8 hours per night consistently may provide optimal health outcomes.⁶

Melatonin use in U.S. adults more than doubled between 2007 and 2012, with a reported 3.1 million users in 2012.⁷ In fact, not all melatonin supplements are the same. Independent supplement testing done by the University of Guelph in 2015 reported melatonin content was found to range from −83% to +478% of the labelled content. Additionally, serotonin was identified in eight of the supplements analyzed.⁸ The key ingredient in REMfresh, UltraMel, is a pharmaceutical grade, 99 percent pure melatonin sourced from Western Europe, where melatonin is a prescription therapy and meets the strictest CGMP manufacturing and testing standards

Over 5,000 healthcare practitioners are estimated to have used REMfresh for their patients and about 320,000 patients are estimated to have purchased and used REMfresh. The continuing, rapid acceptance of REMfresh by patients is observable by several markers, including rapid sales growth and availability among major drug retailers.

About Nonprescription REMfresh®

REMfresh® (CRA-melatonin^™) is the first and only, continuous release and absorption formulation of 0.5mg (Lite), 2 mg and 5mg (Extra Strength) UltraMel® melatonin. UltraMel melatonin is a high-quality, 99 percent ultra-pure melatonin sourced from Western Europe exclusively for Physician's Seal.

REMfresh caplets continuously release bioavailable, 99 percent ultra-pure melatonin over 7 hours, which may help a person fall asleep faster, stay asleep longer and experience quality sleep, such as deep sleep and REM sleep.

REMfresh was designed as a hydrogel matrix tablet with its patented, scientifically advanced Ion-Powered Pump® (IPP®) technology, pioneered by Physician's Seal. Initially, there is a rapid release of the melatonin from the surface of the tablet in the acidic environment of the stomach. As the tablet moves into the higher pH of the small intestine, where melatonin is unlikely to dissolve, acidic factors built inside the tablet maintain a lower pH within the tablet over 7 hours, to allow for continuous release and absorption of active melatonin into the intestines.  

REMfresh is a dietary supplement and is regulated under the Federal Dietary Supplement Health and Education Act, which does not require pre-approval. Melatonin has been in common use for over two decades and has a well-established profile of safe use by millions of people around the world. As with all supplements, individual results may vary.

REMfresh is non-habit forming and does not contain narcotics, hypnotics, barbiturates, sedatives, antihistamines, alcohol or other harsh additive chemicals. The usual adult recommended dose is 1-2 tablets 30-90 minutes before bedtime. Specific dosing instructions found on the back of the box should be followed for proper use of supplements.

REMfresh is available at Walgreens, CVS, Rite Aid, Amazon.com and www.REMfresh.com.

About Physician's Seal®

Physician's Seal® is the innovator of REMfresh®, the first and only continuous release and absorption, 99 percent ultra-pure melatonin (CRA-melatonin™) that mimics the way the body naturally releases and maintains melatonin over a 7-hour period. Physician's Seal (PS), 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.

Physician's Seal's sister subsidiary, IM HealthScience® (IMH), is the innovator of the two medical foods IBgard® and FDgard® for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD or recurring indigestion), respectively. IMH rounds out its line of digestive products with Fiber Choice®, a well-known, natural prebiotic chewable fiber that helps with regularity. In 2017, IMH® is a privately held company based in Boca Raton, Florida. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. Both PS and IMH are dedicated to developing products to address overall health and wellness in digestive health and sleep. The Physician's Seal and IM HealthScience advantage comes from developing products based on patented, targeted-delivery technologies, including IPP® (Ion-Powered Pump®) and SST® (Site Specific Targeting®) technologies. For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com, www.FDgard.com and www.FiberChoice.com.

Media Contact:
Gail S. Thornton
Worldview Communications
908-392-3420
[email protected]

¹Among primary care physicians with a certification in sleep disorders who recommended a brand of melatonin. IQVIA ProVoice Jan.-Feb. 2019 survey.
²Brodner, D.C., Seiden, D.J., & Shah, S.M. 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. (Abstract 0399). Poster Presented at SLEEP 2019, San Antonio, Texas.
³Seiden, D.J., Brodner, D.C., & Shah, S.M. Improvement in Sleep Maintenance and Sleep Quality with Ion Powered Pump Continuous Release and Absorption Melatonin: Results from a Self-Reported Patient Outcomes Study. (Abstract 0419). Poster Presented at SLEEP 2018, Baltimore, Maryland.
⁴Colten, H.R., & Altevogt, B.M. (Eds). Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem.  Institute of Medicine (US) Committee on Sleep Medicine and Research. Washington, DC: National Academies Press (US). 2006; doi: https://doi.org/10.17226/11617. 
⁵Cappuccio, F.P., D'Elia, L., Strazzullo, P., & Miller, M.A. Sleep duration and all-cause mortality: A systemic review and meta-analysis of prospective studies. Sleep. 2010; 33(5):585-592.
⁶Watson, N.F., Badr, M.S., Belenky, G., et al. Joint Consensus Statement of the American Academy of Sleep  Medicine and Sleep Research Society on the Recommended Amount of Sleep for the Healthy Adult, Methodology and Discussion. Journal of Clinical Sleep Medicine. 2015; 11(6); 591-592.
⁷Clarke, T.C., Black, L.I., Stussman, B.J., Barnes, P.M., & Nahin, R.L. Trends in the use of complementary health approaches among adults: United States, 2002–2012. National Health Stat Report. 2015; 79:1–16.
⁸Erland, L.A. & Saxena, P.K. Melatonin natural health products and supplements: presence of serotonin and significant variability of melatonin content. Journal of Clinical Sleep Medicine. 2017; 13(2):275–281.

SOURCE Physician’s Seal, LLC

Related Links

http://www.imhealthscience.com