REMfresh® was designed to mimic the body’s own 7-hour Mesa Wave™, a natural pattern of melatonin blood levels during a normal night’s sleep cycle. A recent clinical study demonstrated the continuous release and absorption of 99 percent 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.
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.3
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 40.4
“Sleep research continues to be important because sleep is an area of unmet medical need,” 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®.
“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 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.”
“The clinical data on REMfresh® represents an unparalleled breakthrough in drug-free sleep maintenance therapy,” said Dr. Brodner. “With the recent launch of non-prescription REMfresh® nationwide earlier this year, it is gratifying to see the remarkably strong patient feedback. The product has strong efficacy along with the ability for patients to wake up the next morning without a drug hangover.”
REMAKT™ Clinical Study Presented At Medical Congress
Pharmacokinetic data on REMfresh® was peer reviewed and then presented in June, 2017 at SLEEP 2017, the Annual Meeting of the Associated Professional Sleep Societies LLC (APSS), and a joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).
The study, REMAKT™ (REM Absorption Kinetics Trial), was a U.S.-based randomized, crossover pharmacokinetic (PK) evaluation study in healthy, non-smoking adults that compared REMfresh® (CRA-melatonin) with a market-leading, immediate-release 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 market-leading 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 prolonged-release 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.
The REMAKT™ data will be submitted for peer review and publication in a medical journal.
QuintilesIMS is a leading integrated information and technology-enabled healthcare service provider worldwide, dedicated to helping its clients improve their clinical, scientific and commercial results. Formed through the merger of Quintiles Transnational Holdings Inc. and IMS Health Holdings, Inc., QuintilesIMS’s approximately 50,000 employees conduct operations in more than 100 countries. Companies seeking to improve real-world patient outcomes through treatment innovations, care provision and access can leverage QuintilesIMS’s broad range of healthcare information, technology and service solutions to drive new insights and approaches. QuintilesIMS provides solutions that span clinical to commercial, bringing customers a unique opportunity to realize the full potential of innovations and advanced healthcare outcomes.
About ProVoice Survey
ProVoice has the largest sample size of any professional healthcare survey in the U.S., with nearly 60,000 respondents across physicians, nurse practitioners, physician assistants, optometrists, dentists and hygienists, measuring recommendations across more than 120 over-the-counter categories. Manufacturers use ProVoice for claim substantiation, promotion measurement and HCP targeting.
QuintilesIMS fielded a U.S. survey among an appropriately powered sample of U.S. primary care physicians with certification in sleep disorders between July 25, 2017, through September 9, 2017, for Physician’s Seal®. The ProVoice survey methodology validated the claim at a 99 percent confidence level that for the first year, “REMfresh® is the #1 recommended modified-release melatonin product for sleep management among sleep specialists.”
About Non-Prescription REMfresh®
REMfresh® (CRA-melatonin) is the first and only, continuous release and absorption formulation of 2 mg UltraMel™ melatonin. UltraMel™ melatonin is a high-quality, 99 percent ultra-pure melatonin sourced from Western Europe exclusively for Physician’s Seal®.
REMfresh® (CRA-melatonin) 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® (CRA-melatonin) was designed as a hydrogel matrix tablet with its patented, scientifically advanced Ion Powered Pump (IPP™) technology, pioneered by Physician’s Seal®. There is 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 in the tablet maintain a lower pH within the tablet over 7 hours to allow for continuous release of active melatonin into the intestines.
REMfresh® (CRA-melatonin) 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® (CRA-melatonin) is non-habit forming and does not contain narcotics, hypnotics, barbiturates, sedatives, antihistamines, alcohol or other harsh or additive chemicals. The usual adult recommended dose is 1-2 tablets 30-60 minutes before bedtime. Follow specific dosing instructions found on the back of the box for proper use of supplements.
REMfresh® (CRA-melatonin) retails for $29.99 for 36 caplets and is available at 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®, 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.
Its sister subsidiary, IM HealthScience® (IMH), is the innovator of IBgard® and FDgard® for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), respectively. In 2017, IMH® added Fiber Choice®, a line of prebiotic fibers, to its product line via an acquisition. 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. The company is dedicated to developing products to address overall health and wellness, including conditions with a high unmet medical need, such as digestive health. The IM HealthScience® advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting (SST®). For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com, www.FDgard.com and www.FiberChoice.com.
1 Colten, H.R., & Altevogt, B.M. (Eds). (2006). 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). doi: https://doi.org/10.17226/11617.
2 The term, modified-release melatonin, encompasses a broad continuum of extended-release products for sleep, including continuous-release, timed-release and sustained-release products.
3 Colten, H.R., & Altevogt, B.M. (Eds). (2006). 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). doi: https://doi.org/10.17226/11617.
4 Zisapel, N. (2010). Melatonin and sleep. The Open Neuroendocrinology Journal, 3: 85-95.
Gail S. Thornton
SOURCE Physician’s Seal
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