Melatonin

PORTLAND, Maine--( BUSINESS WIRE )-- hey freya , the women’s wellness brand radically shifting how women show up in the world and care for themselves, today released new clinical data on its Thrive supplement. The findings validate hey freya’s mission to provide clean, evidence-backed, doctor-formulated solutions that give women the energy and rest needed to live the lives they want and deserve. Most notably, results demonstrated an improvement across all three clinically-used questionnaires for happiness, stress and anxiety, with a 50% improvement on the Generalized Anxiety Disorder 7 screening, which is used clinically to diagnose and monitor anxiety (GAD 7), by week eight. These effects are equivalent to those driven by first-line anti-anxiety medications. It also demonstrated a 66% improvement on the Oxford happiness scale from week four to eight. Results showed improvements in all clinically validated scales at a p-value of <0.0001, meaning there’s a 99.99% chance that these results were due to Thrive. Improvements were observed as early as the first trial check-in point, which is halfway through the trial. “We formulate our products leveraging scientific evidence rooted in naturopathic medicine and herbalism, uniquely designed for women,” said Dr. Thara Vayali, Co-Founder and Chief Medical Officer at hey freya. “We know that a majority of women experience symptoms of stress, anxiety and overwhelm. This clinical trial underscored just how powerful targeted, high-quality ingredients can be for women. The results showed a significant improvement in day-to-day quality of life, which is a huge step in the right direction for us, paving the way for a more robust gold-standard randomized controlled trial against a placebo.” Additional highlights observed at the conclusion of the eight-week trial include: Seventy percent of respondents stated they "felt more like themselves". Seventy-five percent of respondents were less overwhelmed by day-to-day stressors. Seventy-three percent of respondents stated they were more able to cope with everyday life. Seventy-eight percent of respondents stated mood improvement. There was a 70% increase in libido across participants and a 63% improvement in brain fog. Seventy-five percent of participants reported a 73% improvement in fatigue and energy. "It's the year 2024, and many women are still being dismissed by their healthcare providers," said Susanne Mitschke, CEO and co-founder, Citruslabs. “From the very first conversation I had with the hey freya team, I knew they had a one-of-its-kind product. Now, with compelling data to back it up, their supplement showed significant improvements in enhancing happiness, reducing stress and anxiety levels, and boosting energy, focus, concentration, and mental clarity. This is a step towards empowering women to take charge of their health and well-being." The third-party clinical trial, which was conducted by Citruslabs, assessed 38 women 25-50 years old with lasting concerns around energy, fatigue and brain fog through an open label, single-arm, eight-week trial with clinically-validated questions. About hey freya Founded in 2022 by Cecilia Tse, Dr. Thara Vayali, ND, and Helkin Berg, hey freya is the only end-to-end solution helping relieve women's top health concerns through at-home lab testing, naturopathic care, and personalized wellness products formulated by women physicians, specifically for women’s needs. All hey freya products are 100% plant-based and include powerful multivitamins and multiminerals with added stress and anxiety support, daily adaptogenic supplements to reduce feelings of overwhelm, and sleep support without the addition of hormones like melatonin. To learn more about how hey freya is making it easier to address women’s health and wellness symptoms, visit https://www.heyfreya.co/ .

TEL-AVIV, Israel, July 30, 2024 /PRNewswire/ -- Neurim Pharmaceuticals ("Neurim") announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending an extension to the existing indication to include the treatment of Insomnia in children with Neurogenetic disorders (NGDs). Slenyto® is a child appropriate prolonged release melatonin formulation that was approved in the EU in 2018 for the treatment of insomnia in children with autism spectrum disorder (ASD) and/ or Smith-Magenis Syndrome. Slenyto® is the only authorised medication for insomnia in these disorders. The adopted recommended wording for the extended indication is: "Slenyto® is indicated for the treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder (ASD) and/or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient". "The positive CHMP opinion on Slenyto® represents a significant milestone in addressing an unmet need for children with NGDs, who suffer severely from impaired sleep. Upon approval, Slenyto® would be the only medicinal product approved for sleep disorders in this unique paediatric population, allowing treatment initiation at an early age," said Prof. Nava Zisapel, CEO of Neurim Pharmaceuticals. Paul Gringras, Professor of paediatric Sleep Medicine, London, England commented: "Melatonin deficiency or misalignment is a common pathophysiological mechanism for insomnia in neurogenetic disorders. Slenyto® is a prolonged-release formulation of melatonin that delivers melatonin over the course of the night, mimicking the endogenous release profile in healthy subjects. Therefore, Slenyto® has the potential to treat the pathophysiology of insomnia in this population improving sleep latency, sleep continuity and total nighttime sleep duration. Slenyto® has been specifically formulated for use in children and has a favorable safety profile. The treatment will address a significant need in the medical management of many children and adolescents with NGDs". ABOUT INSOMNIA IN CHILDREN WITH NEUROGENETIC DISORDERS (NGDs) Sleep impairment is a common comorbidity in neurogenetic disorders, with up to 86% of children reported to experience disrupted sleep, starting at an early age. During early childhood, sleep plays an essential role in healthy cognitive and psychosocial brain development, influencing learning memory, emotional regulation, and brain structure. Children with neurogenetic disorders tend to develop insomnia and other sleep disorders at an early age. Insomnia has a significant impact on these children, aggravating disease symptoms and reducing quality of life in both patients and caregivers. Current practices recommend parent-directed behavioral sleep interventions as first-line treatment for pediatric insomnia in NGDs, with a 25% response rate. Slenyto® will be the first approved pharmacological treatment for insomnia in children and adolescents with NGDs. ABOUT SLENYTO ® Slenyto® is an age-appropriate prolonged-release formulation of melatonin, a hormone involved in the regulation of circadian clock and sleep. The mini-tablet innovative formulation was specifically designed to facilitate ease of swallowing without resistance in pediatric ASD and NGD population, in response to the unmet medical need in the field of paediatric insomnia. Slenyto® delivers melatonin over the night to mimic the endogenous melatonin release profile in healthy subjects. In a Phase III study in ASD and SMS children and adolescents, Slenyto® improved sleep latency, sleep continuity and total nighttime sleep duration. The positive effect on sleep maintenance and duration was associated with an improvement in externalizing behavior, which correlated with an improvement in parents' well-being. The mechanism of action of Slenyto® on sleep latency, sleep maintenance and total sleep time is independent of the background disorder. Therefore, any patient with a neurogenetic disorder with sleep disturbances associated with aberrant diurnal melatonin secretion patterns and/or insufficient nighttime melatonin secretion will benefit from Slenyto®. ABOUT NEURIM PHARMACEUTICALS Neurim Pharmaceuticals Ltd. () is a neuroscience drug discovery and development company. Its first approved drug, CIRCADIN®, is approved for patients over the age of 55 who are suffering from insomnia and is commercially available in 45 countries around the world, including Europe, Asia-Pacific, Latin America, Africa and the Middle East. Neurim has a strong and innovative product pipeline targeting central nervous system (CNS) disorders. Contact: Guy Manor VP Commercial Operations [email protected]