Market Overview

36-Month Post Marketing Surveillance Report For REMfresh®, The First And Only Drug-Free Sleep Product Of Its Type1, Shows Excellent Safety And Tolerability

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BOCA RATON, Fla., Nov. 5, 2020 /PRNewswire/ -- Physician's Seal, LLC® (PS) today announced results from its REMfresh® Safety Update at 36 Months (REMSU36) for REMfresh® continuous release and absorption melatonin (CRA-melatonin®), a post-marketing surveillance report on the safety and tolerability profile of REMfresh.

REMSU36 involves a post-marketing analysis of the adverse events voluntarily reported by users of a real-world surveillance program reporting on the safety and tolerability profile of REMfresh. It is estimated that 981,735 individual patients used the product during the three-year surveillance period of March 9, 2017 to March 9, 2020.  During that period, REMSU36 captured and analyzed serious and non-serious adverse event reports, and no serious adverse events were reported. The self-reporting rates and patterns of non-serious adverse events were  low with only 81 events recorded with non-serious events received from 81 patients. The four non-serious adverse events most commonly reported, were headache (7), dizziness (5), nightmares (4) and diarrhea (4). The robust scientific literature on melatonin shows that headaches, dizziness and nightmares are often co-morbid conditions for people suffering from chronic sleeplessness.2,3,4  and supports the safety profile of REMfresh. There is also an intricate bi-directional relationship between sleep and the gastro-intestinal (GI) system that can result in a vicious cycle of poor sleep, exacerbating GI symptoms or the GI disease disrupting sleep and circadian function.5

"The findings from REMSU36 reaffirms the safety and tolerability profile of REMfresh in a real-world setting," 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 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.

About REMSU36
The REMfresh® Safety Update at 36 Months (REMSU36) report for REMfresh® involves a post-marketing analysis of the adverse events voluntarily reported by users of REMfresh® from an estimated 981,735 individual patients who used the product from March 2017 to March 2020.

All boxes of REMfresh contain a call-in number for reporting adverse events.  An independent call center with pharmacovigilance-trained health care personnel in accordance with U.S. Food and Drug Administration (FDA)15 and global regulatory guidelines on properly reporting events was retained to receive and record REMfresh customer questions, product issues and adverse events. In addition, a 36-month cluster analysis and trend analysis of adverse events reports received for REMfresh (CRA-melatonin) was conducted by the same personnel.

Melatonin: The Body's Natural Sleep Hormone
Melatonin is produced by the pineal gland in the brain and is the body's natural sleep hormone. Melatonin levels 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 is triggered. Unlike certain prescription hypnotics melatonin-promoted sleep has normal sleep architecture1,6,7-9. Melatonin is associated with both a chronobiotic and hypnotic effect, depending on the dose and timing of administration1,8,10-13.  Importantly, the decline in melatonin levels as people age may contribute to the common complaint of poor sleep quality amongst the elderly.14

About  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 ultrapure melatonin sourced from an FDA DMF-approved facility in Western Europe exclusively for Physician's Seal.

REMfresh is intended to relieve occasional sleeplessness. REMfresh caplets, 99% ultrapure melatonin, that continuously releases and absorbs over 7 hours, is designed to 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, food grade organic acid built inside the tablet, helps maintain a lower pH within the tablet over 7 hours, to allow for continuous release and absorption of active melatonin throughout the GI tract. 

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. Physicians note that melatonin has an advantage compared to many sleep drugs when it comes to morning dysfunction, drowsiness, or unusual night occurrences such as sleepwalking1,6,7-9.  

REMfresh is non-habit forming and does not contain narcotics, hypnotics, barbiturates, sedatives, antihistamines or alcohol. 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 in 0.5mg (Lite), 2mg and 5mg (Extra Strength) versions.

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 ultrapure melatonin (CRA-melatonin®), that mimics the way the body naturally releases and takes up 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 was founded in 2015 by a team of highly experienced pharmaceutical executives. The Company is dedicated to developing products to address overall health and wellness, including digestive health and sleep. The Physician's Seal advantage comes from developing products based on patented, targeted-delivery technologies, including IPP® (Ion-Powered Pump® ) technology. On September 1, 2020 IBgard®, FDgard®, Fiber Choice® and REMfresh were acquired by Nestlé Health Science. For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com, www.FDgard.com and www.FiberChoice.com.

References:

1 Seiden, D.J., & Shah, S.M. A Randomized, Crossover, Pharmacokinetics Evaluation of a Novel Continuous Release and Absorption Melatonin Formulation. Primary Care Companion for CNS Disorders 2019. doi: https://doi.org/10.4088/PCC.19m02450

2 Tran D.P and Spierings E.L. (2013) Headache and insomnia: their relation reviewed; Cranio. Jul; 31(3): 165-70.

3 Schlarb A.S. et.al. (2015) Nightmares and Associations with Sleep Quality and Self-Efficacy among University Students; J. Sleep Disorders and Management; 1:1.

4 Kim S.K. et. al. (2018) Relationship between sleep quality and dizziness; PLoS One. 13(3): e0192705.

5 Johnson, DA, et al. (2018) Sleep Quality Improvement a 'Tremendous Opportunity' in treating GI conditions, Healio, Gastroenterology.

6 Zisapel, N (2010) Melatonin and sleep. The Open Neuroendocrinology Journal. 3:85-95.

7 Cramer H, Rudolph J, Consbruch U, Kendel K. On the effects of melatonin on sleep   and behavior in man. Adv Biochem Psychopharmacol. 1974;11(0):187-191.

 8 Waldhauser F, Saletu B, Trinchard-Lugan I. Sleep laboratory investigations on hypnotic properties of melatonin. Psychopharmacology (Berl). 1990;100(2):222-226.

9 Zhdanova IV, Wurtman RJ. Efficacy of melatonin as a sleep-promoting agent. J Biol Rhythms. 1997;12(6):644-650.

10 Arendt J. Melatonin and human rhythms. Chronobiol Int. 2006;23(1-2):21-37.

11 Tzischinsky O, Lavie P. Melatonin possesses time-dependent hypnotic effects. Sleep. 1994;17(7):638-45.

12 Zhdanova IV. Melatonin as a hypnotic: pro. Sleep Med Rev. 2005;9(1):51-65.

13 Stone BM, Turner C, Mills SL, Nicholson AN. Hypnotic activity of melatonin. Sleep. 2000;23(5):663-9.

14 Zisapel, N (2010) Melatonin and sleep. The Open Neuroendocrinology Journal. 3:85-95.

15 U.S. Food and Drug Administration. Real World Evidence. Retrieved from https://www.fda.gov/scienceresearch/specialtopics/realworldevidence/default.htm
U.S. Food and Drug Administration. 21st Century Cures Act. Retrieved from https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/21stcenturycuresact/default.htm.

Copyright © 2020 REMfresh® This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professional.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.  You should not use this information for diagnosing a health problem or disease. REMfresh is intended to relieve occasional sleeplessness.   Statements made in this release rely upon reviews of literature, input from PS's advisors and PS's own expertise. There may always be other opinions or emphasis points. Some of the statements from different sources may not mesh with each other. There may be inadvertent inaccuracies that PS is not aware of. Space limitations in this release only allow limited reference to some guidelines or practices which may, or may not, be fully agreed to by all scientific, medical or regulatory experts. For any of PS's products this release does not make or have any intent to make drug claims or any comparison or implied claims against FDA approved interventions for sleep disorders. Any comments on any products are based on literature reviews and input from PS's own advisors. There may be others who have other points of view. Pre-clinical findings do not always correlate with clinical or real-world findings. The reader is urged to check all current information, including the latest website disclosures and/or package inserts, of any of the medical products mentioned here, as information, including government regulations, changes all the time. The statements of individual opinions are those of the individuals quoted and do not necessarily reflect opinions of PS. Please fully read all disclaimers/clarifications/explanations. PS disclaims any injury or alleged injury resulting from any ideas, methods, instructions or products referred to here. Health care practitioners should use their independent, professional judgment in helping their patients best manage their sleep conditions. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the most current information can be found on www.REMfresh.com. Individual results may vary.

REMfresh is protected by U.S. Patents No.: 8,691,275; 9,186,351; 9,241,926; 9,549,900, 10,226,447.  Keep out of reach of children. Store at room temperature. Individual results may vary.  Do not use if blister is torn or ripped or if there is any other evidence of tampering. Consult a physician if using any supplement for the first time. Please read package insert and the website for more information.

Media Contact:
Gail S. Thornton
Worldview Communications
908-392-3420
gst@worldviewcomms.com

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SOURCE Physician's Seal

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