NT1

Axsome Therapeutics Announces Results of CRESCENDO Narcolepsy Patient Survey Demonstrating Unmet Needs in Treated Narcolepsy Type 1 Patients

Retrieved on: 
Monday, March 25, 2024
Diagnosis, Neurology, Sleep, Depression, Somnolence, Deficit spending, Thomas Jefferson University, Partnership, Central nervous system, NT1, Cataplexy, Patient, CNS, Sleep disorder, Cognitive deficit, Ageing, EDS, Columbia, Anxiety, Hallucination, Narcolepsy Network, Epworth Sleepiness Scale, Life, Therapy, Sleep paralysis, ESS, Medical director, Idiopathic hypersomnia, FDA, Human, Nursing

NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced topline results from the CRESCENDO (Characterizing Patient Perspectives on Unmet Needs in Narcolepsy) survey of patients with narcolepsy type 1 (NT1, i.e., narcolepsy with cataplexy) receiving treatment, demonstrating high rates of persistent symptoms and significant patient burden, despite being on current treatments. CRESCENDO was conducted in partnership with Narcolepsy Network, a national non-profit patient support organization for people with narcolepsy, idiopathic hypersomnia, and related sleep disorders.

Key Points: 
  • CRESCENDO was conducted in partnership with Narcolepsy Network, a national non-profit patient support organization for people with narcolepsy, idiopathic hypersomnia, and related sleep disorders.
  • All patients taking part in the survey were currently undergoing treatment for NT1.
  • The most common treatments were wake promoting agents (about 53% of surveyed patients), oxybates (47%), and stimulants (42%).
  • Axsome plans to present the detailed results of the CRESCENDO survey at upcoming scientific meetings.

Centessa Pharmaceuticals Announces Preclinical Data Supporting ORX750’s Potential as a Best-in-Class Oral OX2R Agonist for the Treatment of Narcolepsy and Other Sleep-Wake Disorders

Retrieved on: 
Wednesday, October 25, 2023
IH, BRT, Wakefulness, Sleep, Cataplexy, IND, NT2, Human, Congress, Narcolepsy, Electromyography, DTA, Idiopathic hypersomnia, OX2R, OX1R, PK, EC50, EMG, EEG, CHO, Patient, CNTA, Pharmaceutical industry, Aroma compound, Surat Bus Rapid Transit System, NT1

BOSTON and LONDON, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced a robust set of new preclinical data from in vivo and in vitro studies of its investigational, novel orexin receptor 2 (OX2R) agonist, ORX750, that support its potential best-in-class profile for the treatment of narcolepsy and other sleep-wake disorders.

Key Points: 
  • “The preclinical data showed ORX750 achieved maximal wake times and suppressed cataplexy at 0.1 mg/kg, the lowest oral dose tested in the DTA mouse model.
  • Notably, this activity was observed in both the DTA and Atax mouse models that recapitulate NT1 symptoms in humans.
  • Fluorescent imaging plate reader (FLIPR) assay with Chinese hamster ovary (CHO) cells stably expressing recombinant human OX1R or OX2R; OXA EC50 at hOX2R = 0.035 nM.
  • As measured by electroencephalogram (EEG) and electromyogram (EMG) with concurrent video in DTA and Atax mouse models.

Avadel Pharmaceuticals Announces Data Supporting Clinical Profile for LUMRYZ™ (sodium oxybate) for extended-release oral suspension (CIII) at World Sleep 2023

Retrieved on: 
Friday, October 20, 2023
FDA, Headache, Narcolepsy, Incidence, NT2, Food, Health, Vomiting, Dizziness, Epworth Sleepiness Scale, Cataplexy, Nausea, Poster, Senior, EDS, Disease, Enuresis, Avadel Pharmaceuticals, World Sleep Day, Sodium oxybate, Doctor of Pharmacy, Body mass index, Sleep, CIII, Mitigation, Patient, Central nervous system, Pharmaceutical industry, Dietary supplement, NT1

DUBLIN, Ireland, Oct. 20, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today announced new and encore data supporting the clinical profile for LUMRYZ™ (sodium oxybate) for extended-release oral suspension (CIII) and patient preference for a once-nightly oxybate in 15 poster presentations and two oral presentations, at World Sleep 2023, being held from October 20-25, 2023 in Rio de Janeiro, Brazil. LUMRYZ (previously known as FT218), is a U.S. Food and Drug Administration (FDA) approved extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

Key Points: 
  • “We are excited to be at this year’s World Sleep meeting with another robust display of data that supports both the established clinical benefit of LUMRYZ,” said Jennifer Gudeman, PharmD, Senior Vice President, Medical and Clinical Affairs of Avadel.
  • “Quality sleep is a foundational pillar of health for people with narcolepsy, yet ~65% of patients with narcolepsy experience poor, fragmented sleep in addition to their daytime symptoms.
  • LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the LUMRYZ REMS.
  • Most common adverse reactions (incidence > 5% and greater than placebo) reported for all doses of LUMRYZ combined were nausea, dizziness, enuresis, headache, and vomiting.

Alkermes Presents First Clinical Data for Orexin 2 Receptor Agonist ALKS 2680 at World Sleep Congress

Retrieved on: 
Monday, October 23, 2023
DSM-IV codes, MWT, Wireless ambulatory ECG, Congress, Pathology, Dizziness, Idiopathic hypersomnia, Maintenance, Alkermes, Pharmacokinetics, Sleep, Urination, OX2R, Dysfunction, Disease, NT1, Biology, Wakefulness, Sleep onset latency, Safety, Vital signs, ALKS, Patient, Insomnia, Pharmaceutical industry, Narcolepsy

DUBLIN, Oct. 23, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced preliminary results, including initial proof-of-concept data, from a phase 1 study evaluating ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy. The ongoing phase 1 study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in healthy volunteers and patients with narcolepsy or idiopathic hypersomnia via once-daily, oral administration. Initial data from the single- and multiple-ascending dose evaluations in healthy volunteers and the first cohort of four patients with narcolepsy type 1 (NT1) will be presented today at the 2023 World Sleep Congress in Rio de Janeiro.

Key Points: 
  • In the four patients with NT1, treatment with ALKS 2680 demonstrated improved sleep latency compared to placebo at all doses tested, with a clear dose response.
  • The differences between ALKS 2680 and placebo were statistically significant for all doses: 1 mg (p
  • Treatment with ALKS 2680 resulted in clinically meaningful improvements in MWT from baseline at all doses tested.
  • "These initial data support our design rationale for ALKS 2680 as a highly potent, orally bioavailable, selective orexin 2 receptor agonist designed to address the underlying pathology of narcolepsy.

Alkermes Presents First Clinical Data for Orexin 2 Receptor Agonist ALKS 2680 at World Sleep Congress

Retrieved on: 
Monday, October 23, 2023
DSM-IV codes, MWT, Wireless ambulatory ECG, Congress, Pathology, Dizziness, Idiopathic hypersomnia, Maintenance, Alkermes, Pharmacokinetics, Sleep, Urination, OX2R, Dysfunction, Disease, NT1, Biology, Wakefulness, Sleep onset latency, Safety, Vital signs, ALKS, Patient, Insomnia, Pharmaceutical industry, Narcolepsy

DUBLIN, Oct. 23, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced preliminary results, including initial proof-of-concept data, from a phase 1 study evaluating ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy. The ongoing phase 1 study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in healthy volunteers and patients with narcolepsy or idiopathic hypersomnia via once-daily, oral administration. Initial data from the single- and multiple-ascending dose evaluations in healthy volunteers and the first cohort of four patients with narcolepsy type 1 (NT1) will be presented today at the 2023 World Sleep Congress in Rio de Janeiro.

Key Points: 
  • In the four patients with NT1, treatment with ALKS 2680 demonstrated improved sleep latency compared to placebo at all doses tested, with a clear dose response.
  • The differences between ALKS 2680 and placebo were statistically significant for all doses: 1 mg (p
  • Treatment with ALKS 2680 resulted in clinically meaningful improvements in MWT from baseline at all doses tested.
  • "These initial data support our design rationale for ALKS 2680 as a highly potent, orally bioavailable, selective orexin 2 receptor agonist designed to address the underlying pathology of narcolepsy.

Adaptive Immune Response in Narcolepsy Type 1, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, September 27, 2023
NT1, Myenteric plexus, Stanford University School of Medicine, Sleep, Somnolence, Muscle weakness, CSF, Narcolepsy, Emotion, Patient, HLA, RNA, Cerebrospinal fluid, Vaccine

TORONTO, Sept. 27, 2023 /PRNewswire-PRWeb/ -- Narcolepsy — a chronic neurological disorder — affects the brain's capability in controlling the sleep-wake cycles. People affected with narcolepsy might feel rested after waking up, but then feel very sleepy throughout the day. Most people with narcolepsy also experience interrupted and uneven sleep that can involve waking up repeatedly during the night.

Key Points: 
  • In this free webinar, gain insights into an overview of adaptive immune response in narcolepsy.
  • There are two main types of narcolepsy: type 1 and type 2.
  • People with narcolepsy type 2 experience extreme daytime sleepiness but usually don't experience muscle weakness activated by emotions.
  • In this webinar, the featured speaker will share and discuss the following:
    Join this webinar to gain insights on the overview of the adaptive immune response in narcolepsy type 1.

Avadel Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Wednesday, August 9, 2023
Sodium oxybate, Cataplexy, NT2, Pharmacy, EDS, Narcolepsy, Marketing, Anxiety, Sleep, Sleep Research Society, American depositary receipt, NDA, Prescription, American Academy, U.S. FDA, Avadel Pharmaceuticals, American Academy of Sleep Medicine, Patient, NT1, ESI, Somnolence, Growth, FDA, Health, Pharmaceutical industry, Nursing, Fine chemical

DUBLIN, Ireland, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the second quarter ended June 30, 2023.

Key Points: 
  • ET --
    DUBLIN, Ireland, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the second quarter ended June 30, 2023.
  • Recognized $1.5 million in net product revenues for the second quarter 2023.
  • R&D expenses were $4.2 million in the quarter ended June 30, 2023, compared to $4.5 million for the same period in 2022.
  • SG&A expenses were $46.8 million in the quarter ended June 30, 2023, compared to $21.8 million for the same period in 2022.

The New England Journal of Medicine Publishes Data from Phase 2 Study of First Oral Orexin Receptor 2 Agonist TAK-994 in Patients with Narcolepsy Type 1

Retrieved on: 
Wednesday, July 26, 2023
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Hepatotoxicity, Cataplexy, The New England Journal of Medicine, TAK, Narcolepsy, Wakefulness, Patient, OX2R, Somnolence, Disease, Pharmaceutical industry, Takeda, NT1

Takeda ( TSE:4502/NYSE:TAK ) today announced that data from the Phase 2 study of orexin receptor 2 (OX2R) agonist TAK-994 in patients with narcolepsy type 1 (NT1) was published in The New England Journal of Medicine.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that data from the Phase 2 study of orexin receptor 2 (OX2R) agonist TAK-994 in patients with narcolepsy type 1 (NT1) was published in The New England Journal of Medicine.
  • These data represent the first-ever clinical data to be published of an oral orexin agonist in NT1.
  • The article appears in the July 27 issue of the journal and is titled, “Oral Orexin Receptor 2 Agonist in Narcolepsy Type 1.”
    “There is significant unmet need for patients with narcolepsy, a chronic neurologic disease caused by severe loss or absence of the neuropeptide orexin, also known as hypocretin.
  • Today, most patients with NT1 require multiple therapies that only manage excessive daytime sleepiness and cataplexy.

NIO Emerging Carmaker Strategy Research Report 2023: ES6, ET7 and EC6 were the Top Three Models by Sales - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 1, 2023
Automotive Manufacturing, Manufacturing, Atmos, EC6, HD, EEA, Habit, NT2, ADAM, Smartphone, Evocation, Anxiety, OTA, NOP, Perception, IVI, Firefly, NIO, HUD, Lidar, BEV, ALPS, USS, NT3, Radar, ES6, Algorithm, NP, NT1, Architecture, City, Ecosystem, XR, ES7, Dolby Atmos, Navigation, AR, Software, Retail, Satellite navigation device, Rail transport, Instrumentation

The "Emerging Carmaker Strategy Research Report, 2023 - NIO" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Emerging Carmaker Strategy Research Report, 2023 - NIO" report has been added to ResearchAndMarkets.com's offering.
  • As ES7, ET7 and ET5 ("775") were delivered, they saw a rising share of sales.
  • By province, Zhejiang (26,747 units), Jiangsu (18,105 units) and Guangdong (15,626 units) ranked top three by sales.
  • At present, all the cars delivered by NIO are positioned as high-end models priced at higher than RMB300,000.

RØDE NT1 Microphone Updates Venerable with New Digital Features for Recording, Streaming & Podcasting; YouTube Hands On Review, More Info at B&H

Retrieved on: 
Monday, February 20, 2023
Entertainment, Consumer Electronics, Technology, Photography, Audio, Video, Podcast, Vibration, NT1, Human, DSP, SM6, Noise, Electronics, Lyre, Revolution, XLR, Effectiveness, Distortion, Connect, USB, SPL, Cassette tape

NT1 Mic designed for Recording, Streaming & Podcasting

Key Points: 
  • NT1 Mic designed for Recording, Streaming & Podcasting
    Featuring an analog XLR connector and a digital USB-C connector, the RØDE NT1 5th Generation represents another major leap forward for this highly regarded microphone.
  • Behind the protective mesh grille lies RØDE’s gold-sputtered HF6 capsule, a 1" cardioid condenser capsule that delivers detailed midrange response with smooth highs and warm bass.
  • The capsule is then married to the ultra-low noise electronics, resulting in an incredibly quiet microphone with only 4 dBA of self-noise.
  • Finally, the mic comes with a balanced XLR microphone cable and a USB-C cable for connecting to your preferred destination, be it analog or digital.