Wakefulness

Welltory Launches First Personalized AI-generated Bedtime Stories Driven by Users' Heartbeats

Retrieved on: 
Wednesday, March 27, 2024
Narration, Synthetic media, DMN, Relaxation, ASMR, Library, Heart rate, Insomnia, Sleep, Research, AI, Chronic pain, Wakefulness, Human, CDC, Default mode network, Oscillation, Emotion, PTSD

REDWOOD CITY, Calif., March 27, 2024 /PRNewswire/ -- A team of both humans and AI crafted Sleep Flow's endless library. While AI ensures infinite variety, humans play a crucial role in proofreading, infusing stories with emotional depth, and incorporating scientific techniques.

Key Points: 
  • REDWOOD CITY, Calif., March 27, 2024 /PRNewswire/ -- A team of both humans and AI crafted Sleep Flow's endless library.
  • While AI ensures infinite variety, humans play a crucial role in proofreading, infusing stories with emotional depth, and incorporating scientific techniques.
  • Jane Smorodnikova, Welltory's CEO and co-founder, said: "CDC reports that 14.5% of adults in the US have trouble falling asleep nearly every day.
  • That is why we decided that Sleep Flow should never end and constantly surprise users with something fresh and relaxing.

Takeda Intends to Rapidly Initiate the First Global Phase 3 Trials of TAK-861, an Oral Orexin Agonist, in Narcolepsy Type 1 in First Half of Fiscal Year 2024

Retrieved on: 
Thursday, February 8, 2024
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, MRCP, Hepatotoxicity, NT2, Neurological disorder, Narcolepsy, WCR, Fiscal, Wakefulness, Caregiver, Head, Patient, ESS, DSM-IV codes, Medicine, Neuron, OX2R, Disease, Epworth Sleepiness Scale, MWT, Pharmaceutical industry

It is currently classified into two different types: narcolepsy type 1 (NT1) caused by significant loss of orexin neurons with resulting lack of orexin, and narcolepsy type 2 (NT2) where orexin levels are generally normal.

Key Points: 
  • It is currently classified into two different types: narcolepsy type 1 (NT1) caused by significant loss of orexin neurons with resulting lack of orexin, and narcolepsy type 2 (NT2) where orexin levels are generally normal.
  • Stimulating the orexin receptor 2 in NT1 patients targets the underlying pathophysiology of the disease to restore orexin signaling.
  • Based on these results, and in consultation with global health authorities, Takeda plans to initiate global Phase 3 trials of TAK-861 in NT1 rapidly in the first half of its fiscal year 2024.
  • Results from the Phase 2b trials have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023).

Bayer starts Phase II study NIRVANA to evaluate elinzanetant in women with sleep disturbances associated with menopause

Retrieved on: 
Monday, January 8, 2024
Other Health, Research, General Health, Pharmaceutical, Consumer, Mental Health, Clinical Trials, Science, Women, Seniors, Other Science, Health, Psychiatry, WASO, Wakefulness, Metabolism, Woman, VMS, Hot, Executive Committee, Menopause, NIRVANA, Sleep, Field, OASIS, SDM, Safety, Polysomnography, Pharmaceutical industry

The first study participants were recently enrolled into NIRVANA, an exploratory Phase II study to evaluate the efficacy and safety of elinzanetant in women with sleep disturbances associated with menopause (SDM).

Key Points: 
  • The first study participants were recently enrolled into NIRVANA, an exploratory Phase II study to evaluate the efficacy and safety of elinzanetant in women with sleep disturbances associated with menopause (SDM).
  • It is intended to randomize approximately 78 participants in eight countries to investigate the efficacy and safety of elinzanetant in women with sleep disturbances associated with menopause (SDM).
  • The primary endpoint for the NIRVANA study is the efficacy of elinzanetant on Wakefulness After Sleep Onset (WASO) at week 4 as measured by polysomnography.
  • The safety profile observed in the OASIS 1 and 2 studies is overall consistent with previously published data2,6 on elinzanetant.

Human medicines European public assessment report (EPAR): Wakix, pitolisant, Date of authorisation: 31/03/2016, Revision: 16, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, UNS, INN, Neuron, Fatigue, Heartburn, Woman, MWT, Sleep, ATC, Cataplexy, Insomnia, Sleep disorder, Depression, International, Tremor, Epworth Sleepiness Scale, Headache, Wakefulness, ESS, Nausea, Language, Brain, Muscle weakness, Mouth, Dizziness, Vertigo, Breakfast, Anxiety, Irritability, Observational study, European Medicines Agency, Indigestion, Tablet, Histamine, Select, Patient, Safety, Anatomy, Medicine, Somnolence, Vomiting, IIA, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Wakix, pitolisant, Date of authorisation: 31/03/2016, Revision: 16, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Wakix, pitolisant, Date of authorisation: 31/03/2016, Revision: 16, Status: Authorised

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.

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.

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

Retrieved on: 
Tuesday, October 10, 2023
Congress, Neuroscience, BRT, Pharmacokinetics, Idiopathic hypersomnia, Cataplexy, Risk factor, ALKS, Safety, Wakefulness, Risk, Signs and symptoms, Model, OX2R, Investigational New Drug, Diagnosis, Pharmaceutical industry, Alkermes, Narcolepsy, Patient

DUBLIN, Oct. 10, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced plans to present new data related to ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy, at World Sleep Congress, taking place Oct. 20-25, 2023, in Rio de Janeiro. In an oral presentation, the company will present initial data from its ongoing phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in healthy volunteers and patients with narcolepsy or idiopathic hypersomnia. This presentation will include initial clinical proof-of-concept data from the first cohort of four patients with narcolepsy type 1.

Key Points: 
  • — Oral Presentation to Include Initial Clinical Proof-of-Concept Data in Patients With Narcolepsy Type 1 for ALKS 2680, the Company's Investigational Orexin 2 Receptor Agonist —
    DUBLIN, Oct. 10, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced plans to present new data related to ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy, at World Sleep Congress, taking place Oct. 20-25, 2023, in Rio de Janeiro.
  • In an oral presentation, the company will present initial data from its ongoing phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in healthy volunteers and patients with narcolepsy or idiopathic hypersomnia.
  • This presentation will include initial clinical proof-of-concept data from the first cohort of four patients with narcolepsy type 1.
  • We look forward to presenting data at the World Sleep Congress, including our first clinical data for ALKS 2680 in patients with narcolepsy."

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

Retrieved on: 
Tuesday, October 10, 2023
Congress, Neuroscience, BRT, Pharmacokinetics, Idiopathic hypersomnia, Cataplexy, Risk factor, ALKS, Safety, Wakefulness, Risk, Signs and symptoms, Model, OX2R, Investigational New Drug, Diagnosis, Pharmaceutical industry, Alkermes, Narcolepsy, Patient

DUBLIN, Oct. 10, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced plans to present new data related to ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy, at World Sleep Congress, taking place Oct. 20-25, 2023, in Rio de Janeiro. In an oral presentation, the company will present initial data from its ongoing phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in healthy volunteers and patients with narcolepsy or idiopathic hypersomnia. This presentation will include initial clinical proof-of-concept data from the first cohort of four patients with narcolepsy type 1.

Key Points: 
  • — Oral Presentation to Include Initial Clinical Proof-of-Concept Data in Patients With Narcolepsy Type 1 for ALKS 2680, the Company's Investigational Orexin 2 Receptor Agonist —
    DUBLIN, Oct. 10, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced plans to present new data related to ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy, at World Sleep Congress, taking place Oct. 20-25, 2023, in Rio de Janeiro.
  • In an oral presentation, the company will present initial data from its ongoing phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in healthy volunteers and patients with narcolepsy or idiopathic hypersomnia.
  • This presentation will include initial clinical proof-of-concept data from the first cohort of four patients with narcolepsy type 1.
  • We look forward to presenting data at the World Sleep Congress, including our first clinical data for ALKS 2680 in patients with narcolepsy."

HARMONY BIOSCIENCES ANNOUNCES US FOOD & DRUG ADMINISTRATION ORPHAN DRUG DESIGNATION FOR PITOLISANT FOR TREATMENT OF IDIOPATHIC HYPERSOMNIA

Retrieved on: 
Thursday, September 7, 2023
Idiopathic hypersomnia, Histamine, IH, DSM-IV codes, Wakefulness, Harmony, Orphan drug, Patient, Rare, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

PLYMOUTH MEETING, Pa., Sept. 7, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of idiopathic hypersomnia (IH).

Key Points: 
  • PLYMOUTH MEETING, Pa., Sept. 7, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of idiopathic hypersomnia (IH).
  • The FDA's Orphan Drug designation incentivizes the advancement of promising therapies for rare diseases.
  • Approximately 80,000 people in the U.S. are believed to be affected by IH, with 40,000 currently having been diagnosed.
  • Harmony is currently evaluating the efficacy and safety of pitolisant in adult patients with IH in the Phase 3 registrational INTUNE study, a double-blind, placebo-controlled, randomized withdrawal study.