Latest news with #narcolepsy
Medscape
3 days ago
- Health
- Medscape
SLEEP 2025
Narcolepsy an Independent Cardiovascular Disease Risk Factor Narcolepsy is associated with an increased risk for CVD, independent of common comorbid conditions and medications used to treat the disorder, new research showed. Medscape Medical News , Jun 07, 2024 Narcolepsy an Independent Cardiovascular Disease Risk Factor Better Sleep Tied to Less Loneliness Good quality sleep may have a role in driving down rates of loneliness, especially among younger adults. Medscape Medical News , Jun 21, 2024 Better Sleep Tied to Less Loneliness Couples-Based Tx for Sleep Apnea Nurtures Happier Relationships Couples-based therapy called WePAP boosted treatment adherence for sleep apnea, leading to higher relationship satisfaction and lower levels of conflict, a study suggested. Medscape Medical News, xx-Date-Here-xx
Yahoo
31-05-2025
- Business
- Yahoo
Avadel Pharmaceuticals plc (AVDL) Showcases LUMRYZ Success with 14 Abstracts, 4 Oral Presentations at SLEEP 2025
Avadel Pharmaceuticals plc (NASDAQ:AVDL) announced it will present 14 new abstracts, including four oral presentations, at SLEEP 2025, highlighting significant advances for LUMRYZ, its once-at-bedtime sodium oxybate treatment for narcolepsy. Interim results from the real-world REFRESH study showed that patients switching from twice-nightly oxybate to LUMRYZ experienced clinically meaningful improvements in excessive daytime sleepiness (EDS), with many achieving normal Epworth Sleepiness Scale (ESS) scores. A scientist in a labcoat examining a vial of experimental biopharmaceuticals. Additional analyses from the pivotal Phase 3 REST-ON trial revealed that even those with the most severe baseline sleepiness saw their ESS scores normalize after 13 weeks on LUMRYZ, and the therapy did not worsen sleep apnea. Further data demonstrated a reduction in distressing hallucinations and improvement in sleep-related eating disorder (SRED) symptoms after switching to LUMRYZ. Long-term tolerability was underscored, with only 4% discontinuing due to side effects. Avadel Pharmaceuticals plc (NASDAQ:AVDL) emphasized that LUMRYZ, FDA-approved for adults and children aged 7 and older, offers a major benefit over traditional oxybate by eliminating the need for middle-of-the-night dosing, supporting better sleep continuity and patient care. With these compelling results, Avadel Pharmaceuticals plc (NASDAQ:AVDL) continues to solidify its leadership in innovative narcolepsy treatments. While we acknowledge the potential of AVDL to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than AVDL and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
National Post
14-05-2025
- Health
- National Post
The New England Journal of Medicine Publishes Data from Phase 2b Trial of Oral Orexin Receptor 2 Agonist Oveporexton (TAK-861) in People with Narcolepsy Type 1
Article content –Data Demonstrated Statistically Significant Improvements in Primary and Secondary Endpoints with Most Subjects Achieving Near Normal Ranges of Wakefulness and Clinically Meaningful Improvements Across the Broad Range of Symptoms Investigated Article content OSAKA, Japan & CAMBRIDGE, Mass. — Takeda ( TSE: 4502/NYSE:TAK) today announced that the New England Journal of Medicine published data from the Phase 2b trial of oveporexton (TAK-861) in people with narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to restore orexin signaling to address the underlying orexin deficiency that causes NT1. Results demonstrated significant improvement in objective and subjective measures of excessive daytime sleepiness (EDS), reductions in cataplexy events and clinically meaningful improvements in disease severity and quality of life across all doses tested compared to placebo through eight weeks of treatment. Article content NT1 is a severe, chronic neurological condition caused by a significant loss of orexin-producing neurons, resulting in low levels of orexin leading to EDS, cataplexy (sudden loss of muscle tone), cognitive symptoms, disrupted nighttime sleep, hallucinations that occur as one falls asleep or wakes up and sleep paralysis. These debilitating symptoms can markedly reduce an individual's quality of life and severely impact job performance, academic achievement and personal relationships. Current standard of care includes polypharmacy to manage different symptoms, but none of these medicines target the underlying orexin deficiency that causes NT1. Article content 'Narcolepsy type 1 is a 24-hour disease making it very challenging to function and lead a healthy, productive life,' said principal investigator Yves Dauvilliers, M.D., Director, Sleep-Wake Disorders Center, Department of Neurology, Gui de Chauliac Hospital, Montpellier, France. 'Oveporexton is the leading investigational orexin receptor 2 agonist designed to address the underlying pathophysiology of NT1. The supporting data from Takeda's Phase 2b trial demonstrated clinically meaningful improvements across the full spectrum of symptoms impacting people with NT1.' Article content 'For people living with narcolepsy type 1, going to work or attending school and managing everyday activities like driving, exercising or socializing with family and friends can become daunting challenges,' said Sarah Sheikh, M.D., B.M., MRCP, Head of the Neuroscience Therapeutic Area Unit and Global Development at Takeda. 'Our Phase 2b results suggest that restoring orexin signaling has the potential to help people with narcolepsy type 1 achieve near normal ranges of wakefulness as seen in healthy individuals while also positively impacting the broader spectrum of the disease. We are working diligently to further investigate oveporexton and its potential to become the first-in-class, transformative therapeutic option for people living with NT1.' Article content The TAK-861-2001 Phase 2b trial enrolled 112 adults aged 18−70 with NT1 globally. Participants were randomized equally to one of four dosing arms (twice-daily 0.5/0.5 mg, 2/2 mg, 2/5 mg or once-daily 7 mg) or placebo for 8 weeks. The primary and secondary endpoints from the study assessed the impact of oveporexton across subjective and objective measures of wakefulness and daytime sleepiness, cataplexy rates and safety compared to placebo. Article content The primary endpoint demonstrated substantial increases in mean sleep latency on the Maintenance of Wakefulness Test (MWT), a key measure of wakefulness, with improvements across all doses compared to placebo (adjusted p ≤0.001 for all comparisons) sustained over 8 weeks. The mean sleep latency on the MWT reached values consistent with normative values seen in healthy individuals. Key secondary endpoints demonstrated significant reductions in Epworth Sleepiness Scale (ESS) scores, a measure of EDS, and reductions in Weekly Cataplexy Rate (WCR) across all doses compared to placebo and were sustained over 8 weeks. The Narcolepsy Severity Scale for Clinical Trials (NSS-CT), a self-assessment scale used to assess the severity, frequency and impact across narcolepsy symptoms, and the 36-item short-form (SF-36), used to assess quality of life, were evaluated as exploratory endpoints. NSS-CT domain scores indicated marked improvements across most domains (EDS, cataplexy, hypnagogic hallucinations and sleep paralysis) while clinically meaningful improvements in quality of life as assessed with the SF-36 questionnaire were observed with all oveporexton dose groups compared to placebo. The most commonly reported treatment-emergent adverse events (TEAEs) were insomnia (43%), increased urinary urgency (30%) and frequency (29%). Most TEAEs were mild to moderate in intensity, and most started within 1-2 days of treatment and were transient. No cases of hepatotoxicity or visual disturbances were reported. The majority of participants (95%) who completed the trial enrolled in the long-term extension (LTE) study, with many patients reaching one year or more of treatment. Article content Takeda is leading the field of orexin science with a multi-asset franchise. Oveporexton, the lead program in the franchise, is the first and only orexin agonist in Phase 3 trials. Takeda anticipates a data readout from the Phase 3 trials in calendar year 2025. Article content Takeda is pioneering the field of orexin science with a multi-asset franchise offering tailored treatments. Orexin is a key regulator of the sleep-wake cycle and is involved in other essential functions, including respiration and metabolism. Oveporexton (TAK-861) is the leading investigational asset in this franchise and received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in narcolepsy type 1 from the U.S. Food and Drug Administration (FDA) and Center for Drug Evaluation of China's National Medical Products Administration. The company is also progressing orexin agonists in patient populations with normal levels of orexin neuropeptides and other indications where orexin biology is implicated. This includes TAK-360, an oral OX2R agonist being investigated for narcolepsy type 2 and idiopathic hypersomnia, which received Fast Track designation from the FDA. Article content About Takeda Article content Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. 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Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Article content Article content Article content Article content Article content Contacts Article content Media Contacts: Article content Japanese Media Yuko Yoneyama Article content Article content
