Second study, REMfresh Patient Reported Outcomes DURation (REMDUR), peer-reviewed and presented at a major sleep medicine conference, SLEEP 2018, provided confirmatory real-world evidence of the 7-hour action of REMfresh.
- Drug-free, nonprescription REMfresh®, the first continuous release and absorption melatonin (CRA-melatonin™), ranks for a second year as the #1 recommended modified-release melatonin brand - and for the first year as the #1 recommended melatonin brand overall by primary care physicians with certification in sleep disorders.
- Previously presented clinical study, REM Absorption Kinetics Trial (REMAKT), demonstrated REMfresh, a scientific breakthrough in sleep management with its continuous release and absorption, 99 percent ultra-pure melatonin (CRA-melatonin), mimics the body’s own 7-hour Mesa Wave® a natural pattern of melatonin blood levels during a normal night’s sleep cycle.
- Second study, REMfresh Patient Reported Outcomes DURation (REMDUR), peer-reviewed and presented at a major sleep medicine conference, SLEEP 2018, provided confirmatory real-world evidence of the 7-hour action of REMfresh.
BOCA RATON, Fla., April 9, 2019 /PRNewswire/ -- Physician’s Seal, LLC®, innovators of REMfresh® (CRA-melatonin™), a clinically studied, drug-free, nonprescription sleep brand, revealed positive results of a nationwide survey conducted among 863 U.S. primary care physicians with certification in sleep disorders. These primary sleep specialists broadened their endorsement for REMfresh as both the #1 recommended modified-release melatonin brand for the second consecutive year and the #1 recommended melatonin brand overall for the first year for sleep management.
“Growing, widespread adoption of REMfresh among primary care physicians with certification in sleep disorders reflects an increased willingness to recommend this brand based on their real-world experience in receiving positive feedback from their patients who suffer from sleep disturbances,” said David C. Brodner, M.D., a leading sleep specialist who is Double Board-Certified in Otolaryngology – Head of 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.
Over 5,000 healthcare practitioners are estimated to have used REMfresh for their patients.
About IQVIA 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, dentist and hygienists, measuring recommendations across more than 120 over-the-counter categories. Manufacturers use ProVoice for claim substantiation, promotion measurement and HCP targeting.
IQVIA fielded a U.S. survey among 863 primary care physicians with certification in sleep disorders between January 22, 2019, through February 24, 2019, for Physician’s Seal. The ProVoice survey methodology validated the claim at a 95 percent confidence level that for the second year, “REMfresh® is the #1 recommended modified-release melatonin brand among primary care physicians with certification in sleep disorders, and for the first year as the #1 recommended melatonin brand among this same cohort.
IQVIA is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry formed through the merger of IMS Health and Quintiles.
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.
REM Absorption Kinetics Trial (REMAKT), a U.S.-based randomized, crossover pharmacokinetic (PK) evaluation study in healthy, non-smoking adults compared REMfresh (CRA-melatonin) with a market-leading, immediate-release melatonin (IR-melatonin).
The study results, which were peer-reviewed and presented at SLEEP 2017 and 2018, showed 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.
Subsequently, the post marketing REMfresh Patient Reported Outcomes DURation (REMDUR) study was peer-reviewed and presented at SLEEP 2018, the 32nd Annual Meeting of the Associated Professional Sleep Societies (APSS), LLC, a joint partnership of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS). In a sample of 500 patients on REMfresh responding to an online survey, 77.6 percent achieved 6 or more hours of sleep compared to 23.6 percent who slept that duration prior to taking REMfresh (p<.0001). A vast majority of respondents also reported a major or moderate improvement in sleep onset (91.6 percent, p<.0001), sleep maintenance (94.8 percent, p<.0001) and total sleep quality (97.2 percent, p<.0001). More than three quarters (76.6 percent) of patients indicated they take REMfresh nightly. The proportion of patients reporting nightly CRA-melatonin use was significantly greater than the proportion of patients with less than nightly use (p<.0001). Most importantly, over 98 percent of patients reported they were very likely or likely to continue taking REMfresh (CRA-melatonin) to treat their sleep complaints.
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. Additionally, the REM Safety Update at 12 months (REMSU-12), a 12-month post-marketing safety study, showed no pattern of side effects. 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 in 0.5mg (Lite), 2mg and 5mg (Extra Strength) versions.
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.
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. 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. 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.
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. You should not use this information for diagnosing a health problem or disease. 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.
Media Contact:
Gail S. Thornton
Worldview Communications
908-392-3420
gst@worldviewcomms.com
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