Sodium oxybate

Avadel Pharmaceuticals Shares New LUMRYZ™ (sodium oxybate) For Extended-release Oral Suspension (CIII) Data at SLEEP 2024

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星期三, 五月 22, 2024
Sleep, Patient, American Academy, Headache, Water, Food, Avadel Pharmaceuticals, Nausea, FDA, Collection, Doctor of Pharmacy, Dizziness, Sodium oxybate, Sleep Research Society, DNS, Cataplexy, Senior, Incidence, EDS, Narcolepsy, Mitigation, Enuresis, Abstract, Central nervous system, Vomiting, Family, Polysomnography, Pharmaceutical industry

DUBLIN, May 22, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, announced today it will present 11 posters, and one oral presentation, supporting the use of LUMRYZ as a narcolepsy treatment option at SLEEP 2024, the 38th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society on June 1-5, 2024, in Houston.

Key Points: 
  • LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the LUMRYZ REMS.
  • Additionally, objective data from polysomnography showed worse disrupted nighttime sleep (DNS) in older participants, indicating DNS may worsen with age.
  • All abstracts have been published in an online supplement in the journal Sleep .
  • Presentation details are as follows:
    Composite Response With Once-Nightly Sodium Oxybate: Symptom Improvement in Participants With Narcolepsy Type 1 in REST-ON

Narcolepsy Drugs Market, Size, Global Forecast 2024-2030: Industry Trends, Share, Growth, Insight, Impact of Inflation, Company Analysis - ResearchAndMarkets.com

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星期五, 十二月 29, 2023
Health, Pharmaceutical, Novartis, Teva Pharmaceuticals, Quality of life, Sodium oxybate, Food, Risk, Drug development, Takeda Pharmaceutical Company, Roche, Research, Cataplexy, FDA, Instability, Prevalence, NINDS, Incidence, Mazindol, GHB, Stimulant, EDS, NMPA, Narcolepsy, Tobacco, DSM-IV codes, Investment, Patient, Diagnosis, Organization, Somnolence, Neurological disorder, Pharmaceutical industry

The "Narcolepsy Drugs Market, Size, Global Forecast 2024-2030, Industry Trends, Share, Growth, Insight, Impact of Inflation, Company Analysis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Narcolepsy Drugs Market, Size, Global Forecast 2024-2030, Industry Trends, Share, Growth, Insight, Impact of Inflation, Company Analysis" report has been added to ResearchAndMarkets.com's offering.
  • The Global Narcolepsy Drugs Market is poised for substantial growth, with a projected value of US$5.95 billion by 2030
    Several factors contribute to the expansion of the narcolepsy drugs market.
  • The Narcolepsy Drugs Market is expected to grow steadily, with a compound annual growth rate (CAGR) of 8.01% from 2023 to 2030.
  • Combined, these elements make the U.S. narcolepsy drugs market a leader in global healthcare.

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

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星期五, 十月 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.

Jazz Pharmaceuticals Presents Data Highlighting the Continued Need for Low-Sodium Treatment Option Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution and Real-World, Evidence-Based Approaches for Individualized Treatment in Adults w

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星期一, 十月 23, 2023
MB, Jazz Pharmaceuticals, Sodium, Mercury (element), Literature, Blood pressure, Congress, Narcolepsy, MD, Observational study, American Heart Association, Cataplexy, Disease, Idiopathic hypersomnia, Systematic review, Gamma-Hydroxybutyric acid, Sleep, Magnesium, American Heart, Risk, Somnolence, Colorado Ultraviolet Transit Experiment, Patient, Calcium, MRCPCH, Potassium, Medicine, Diagnosis, Cardiovascular disease, Mercury, Salt, Pharmaceutical industry, Person, Sodium oxybate, Xywav

DUBLIN, Oct. 23, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced new data that examine the comorbid risk of cardiovascular disease in patients with narcolepsy and idiopathic hypersomnia as well as the effect of sodium intake on cardiovascular health. The Company will also present results from the real-world TENOR study on individualized dosing regimens for adults with type 1 or type 2 narcolepsy transitioning to low-sodium Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution from high-sodium Xyrem® (sodium oxybate) oral solution. The study will be presented today at the World Sleep 2023 Congress in an oral session on evidence-based approaches for optimizing pharmacologic treatment for narcolepsy.

Key Points: 
  • The Company will also present results from the real-world TENOR study on individualized dosing regimens for adults with type 1 or type 2 narcolepsy transitioning to low-sodium Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution from high-sodium Xyrem® (sodium oxybate) oral solution.
  • The study will be presented today at the World Sleep 2023 Congress in an oral session on evidence-based approaches for optimizing pharmacologic treatment for narcolepsy.
  • "Real-world data regarding individualized dosing regimens for the treatment of narcolepsy are limited.
  • The TENOR study was a patient-centric, prospective, observational study of U.S. adults with type 1 or type 2 narcolepsy.

Jazz Pharmaceuticals to Present Latest Advancements in Sleep Medicine at World Sleep 2023

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星期三, 十月 18, 2023
Jazz Pharmaceuticals, Stroke, Splenic infarction, Sleep disorder, Sodium, MSCE, Literature, Blood pressure, Sleep medicine, Congress, Narcolepsy, Prevalence, Idiopathic hypersomnia, Systematic review, Research, Sleep, Magnesium, Sodium oxybate, SEGUE, Abstract, Cancer, CV, Patient, Calcium, Potassium, Heart failure, Medicine, Cardiovascular disease, Nightclub, Pharmaceutical industry, MD

DUBLIN, Oct. 18, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company and its partners will present 14 abstracts from across its sleep medicine portfolio, including two oral presentations, at the 17th annual World Sleep 2023 Congress, held October 20-25 in Rio de Janeiro, Brazil.

Key Points: 
  • DUBLIN, Oct. 18, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company and its partners will present 14 abstracts from across its sleep medicine portfolio, including two oral presentations, at the 17th annual World Sleep 2023 Congress, held October 20-25 in Rio de Janeiro, Brazil.
  • The oral presentations include findings from the real-world TENOR study, which demonstrated individualized dosing strategies for twice-nightly oxybate treatment in narcolepsy.
  • The World Sleep 2023 schedule is available online and outlines all abstracts, posters and oral presentations slated to be shared at the congress.
  • All abstracts are published in a supplemental issue of Sleep Medicine, the official journal of World Sleep Society, two months after the event.

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

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星期三, 八月 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.

Girard Sharp LLP and Motley Rice LLC Announce a Proposed Settlement in In re Xyrem (Sodium Oxybate) Antitrust Litigation

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星期五, 七月 28, 2023
Amneal Pharmaceuticals, Damages, Lupin Limited, Class, Parent, Xywav, Nestlé USA, Inc. v. Doe, Person, Injunctive, District court, Settlement, Express Scripts, Court order, Punitive damages, Court, Defendant, City, Federal Employees Health Benefits Program, Tobacco, Insurance, Sodium oxybate

The plaintiffs in the lawsuit have reached a proposed Settlement with the Amneal and Lupin defendants that would resolve all claims against them.

Key Points: 
  • The plaintiffs in the lawsuit have reached a proposed Settlement with the Amneal and Lupin defendants that would resolve all claims against them.
  • Separately, the Court has certified several classes of Xyrem and/or Xywav payers and the claims of those classes against the remaining defendants will continue.
  • The proposed Settlement and the Court's class certification order may affect the rights of members of the Settlement Class, the Damages Class and the Injunctive Relief Class (all defined below).
  • But they give up any rights to sue the Defendants separately about the same legal claims in this lawsuit.

Amneal Launches Authorized Generic for Xyrem® (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter

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星期一, 七月 3, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Seizure, Sodium chloride, Dapsone, Central nervous system, Depression, Medicine, GHB, Hypotension, Anxiety, Nelarabine, USP, Suicide, CNS, Abuse, Syncope, Mometasone, Hypoventilation, Medroxyprogesterone acetate, Coma, Confusion, Dexmedetomidine, Patient, Injection (medicine), Death, Sodium oxybate, Consciousness, Birth control, Pharmaceutical industry, Medroxyprogesterone

Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 4 mcg/mL (200 mcg/50 mL and 400 mcg/100 mL) is a generic version of Precedex® Injection.

Key Points: 
  • Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 4 mcg/mL (200 mcg/50 mL and 400 mcg/100 mL) is a generic version of Precedex® Injection.
  • For full prescribing information, see package insert located here .
  • Nelarabine injection, 250mg/50mL (5mg/mL) is a generic version of Arranon® Injection.
  • Patients must be enrolled in the XYWAV and XYREM REMS to receive Sodium Oxybate Oral Solution.

D&A Pharma : Despite the latest alarming figures on alcohol dependence, France is delaying the use of sodium oxybate, which has been prescribed for almost 30 years in Italy and Austria

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星期四, 六月 22, 2023
Faculty, Sodium oxybate, University, European Medicines Agency, Hope, Tobacco, Death, Patient, University of Toronto Faculty of Medicine, Health, Safety, Pharmaceutical industry, Medicine

The results are alarming: every year in France, alcohol is the cause of 49,000 deaths and an estimated social cost of 118 billion euros.1 Two figures that dramatically sum up the human and financial cost of alcohol dependence, the second leading cause of death after tobacco.

Key Points: 
  • The results are alarming: every year in France, alcohol is the cause of 49,000 deaths and an estimated social cost of 118 billion euros.1 Two figures that dramatically sum up the human and financial cost of alcohol dependence, the second leading cause of death after tobacco.
  • Yet there is a drug whose efficacy has recently been reaffirmed, and which has been prescribed in Italy and Austria for over 30 years to 300,000 patients.
  • Its active ingredient, sodium oxybate, was discovered by French professor Henri Laborit, and is used to help alcohol-dependent people maintaining abstinence.
  • A university thesis on the subject has just been published by the Faculty of Medicine at the University of Amsterdam.

D&A Pharma : Despite the latest alarming figures on alcohol dependence, France is delaying the use of sodium oxybate, which has been prescribed for almost 30 years in Italy and Austria

Retrieved on: 
星期四, 六月 22, 2023
Faculty, Sodium oxybate, University, European Medicines Agency, Hope, Tobacco, Death, Patient, University of Toronto Faculty of Medicine, Health, Safety, Pharmaceutical industry, Medicine

The results are alarming: every year in France, alcohol is the cause of 49,000 deaths and an estimated social cost of 118 billion euros.1 Two figures that dramatically sum up the human and financial cost of alcohol dependence, the second leading cause of death after tobacco.

Key Points: 
  • The results are alarming: every year in France, alcohol is the cause of 49,000 deaths and an estimated social cost of 118 billion euros.1 Two figures that dramatically sum up the human and financial cost of alcohol dependence, the second leading cause of death after tobacco.
  • Yet there is a drug whose efficacy has recently been reaffirmed, and which has been prescribed in Italy and Austria for over 30 years to 300,000 patients.
  • Its active ingredient, sodium oxybate, was discovered by French professor Henri Laborit, and is used to help alcohol-dependent people maintaining abstinence.
  • A university thesis on the subject has just been published by the Faculty of Medicine at the University of Amsterdam.