Idiopathic hypersomnia

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

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水曜日, 10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.

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

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火曜日, 10月 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: 
火曜日, 10月 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."

Zevra Therapeutics Announces Interim Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia

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月曜日, 10月 2, 2023
Senior, Idiopathic hypersomnia, Doctor of Philosophy, Overalls, Drug, Brain, Sleep inertia, Zebra, Patient, Somnolence, SDX, Therapy, Safety, Disease, Pharmaceutical industry, IH

CELEBRATION, Fla., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, announced interim data from the open-label dose titration phase of the Phase 2 clinical trial evaluating KP1077 in patients with idiopathic hypersomnia (IH). The data provide valuable information on the primary endpoint of the trial, which is the safety and tolerability of KP1077 in patients with IH, as well as insights related to the effective dose range and regimen. Topline data from the completed trial are expected in the first half of 2024 after all patients have completed the double-blind withdrawal phase. The combined open-label interim and upcoming topline data are expected to also provide information related to a number of secondary and exploratory endpoints, including excessive daytime sleepiness, sleep inertia, and brain fog.

Key Points: 
  • Data generated to date indicate SDX is well-tolerated across all doses and both dosing regimens studied, laying the groundwork for future Phase 3 trial
    Topline data from completed trial expected in the first half 2024, with potential to initiate Phase 3 trial by the end of 2024
    CELEBRATION, Fla., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, announced interim data from the open-label dose titration phase of the Phase 2 clinical trial evaluating KP1077 in patients with idiopathic hypersomnia (IH).
  • Topline data from the completed trial are expected in the first half of 2024 after all patients have completed the double-blind withdrawal phase.
  • “The open-label data yielded key insights for the design of the Phase 3 trial and potential unique benefits of KP1077 as a treatment for IH, if approved,” said Rene Braeckman, Ph.D., Senior Vice President of Clinical Development.
  • The results from the completed Phase 2 trial are expected to inform the final design of the anticipated Phase 3 trial in IH, which is expected to be initiated by the end of 2024.

Zevra Therapeutics Presents Full Data Set on the Cardiovascular Safety and Pharmacokinetics of SDX, the sole API in KP1077, in Healthy Volunteers at Psych Congress 2023

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日曜日, 9月 10, 2023
Psych, Idiopathic hypersomnia, Doctor of Philosophy, Safety, API, IH, Drug, Research, Zebra, Congress, Comparative Effectiveness Research Translation Network, Methylphenidate, Vital signs, Somnolence, Poster, SDX, Therapy, Sleep, Disease, Pharmaceutical industry, Pharmacokinetics

In addition, both doses of SDX were generally better tolerated compared to Ritalin and fewer subjects experienced cardiovascular adverse events after SDX compared to Ritalin.

Key Points: 
  • In addition, both doses of SDX were generally better tolerated compared to Ritalin and fewer subjects experienced cardiovascular adverse events after SDX compared to Ritalin.
  • Lastly, vital signs after a single oral dose of 200 mg SDX (the highest dose tested) were comparable to Ritalin IR 80 mg and Ritalin LA 80 mg.
  • The results demonstrate a robust safety profile for SDX, positioning it as a promising option for treating sleep disorders characterized by excessive daytime sleepiness.
  • Details of Zevra’s poster presentation are as follows:
    Sr. Vice President of Clinical Development, Zevra Therapeutics

Jazz Pharmaceuticals Showcases Impact of Sleep Medicine Portfolio at Psych Congress 2023

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月曜日, 9月 11, 2023
Psych, Abstract, Abstract (summary), Bachelor of Medicine, Bachelor of Surgery, Narcolepsy, Depression, University, Idiopathic hypersomnia, Magnesium, Anxiety, Safety, Efficacy, Quality of life, Medical school, Research, Mental health, Disruption, Calcium, DSM-IV codes, Literature, Patient, Sleep disorder, Physician, Psychiatry, FCCP, MRCPCH, Jazz Pharmaceuticals, Potassium, Pharmaceutical industry, Sleep, Gamma-Hydroxybutyric acid, MD, Medicine

DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that six abstracts presenting data from across its sleep medicine portfolio were featured at the 36th annual Psych Congress, held September 6-10, 2023. One of the accepted abstracts provided a comprehensive review of clinical data that assessed the impact of oxybate on sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy. Oxybate is the active ingredient in Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution.

Key Points: 
  • Review of multiple clinical trials provided a comprehensive analysis showing that oxybate improves sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy, independent of once- or twice-nightly dosing
    DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that six abstracts presenting data from across its sleep medicine portfolio were featured at the 36th annual Psych Congress, held September 6-10, 2023.
  • One of the accepted abstracts provided a comprehensive review of clinical data that assessed the impact of oxybate on sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy.
  • The review found that oxybate improved measures of sleep architecture and disrupted nighttime sleep in narcolepsy patients, independent of dosing regimen or prior oxybate experience.
  • "Idiopathic hypersomnia has a profound impact on those who live with this debilitating sleep disorder," said Kelvin Tan, MBBCh, MRCPCH, senior vice president and chief medical officer of Jazz Pharmaceuticals.

Jazz Pharmaceuticals Showcases Impact of Sleep Medicine Portfolio at Psych Congress 2023

Retrieved on: 
月曜日, 9月 11, 2023
Psych, Abstract, Abstract (summary), Bachelor of Medicine, Bachelor of Surgery, Narcolepsy, Depression, University, Idiopathic hypersomnia, Magnesium, Anxiety, Safety, Efficacy, Quality of life, Medical school, Research, Mental health, Disruption, Calcium, DSM-IV codes, Literature, Patient, Sleep disorder, Physician, Psychiatry, FCCP, MRCPCH, Jazz Pharmaceuticals, Potassium, Pharmaceutical industry, Sleep, Gamma-Hydroxybutyric acid, MD, Medicine

DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that six abstracts presenting data from across its sleep medicine portfolio were featured at the 36th annual Psych Congress, held September 6-10, 2023. One of the accepted abstracts provided a comprehensive review of clinical data that assessed the impact of oxybate on sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy. Oxybate is the active ingredient in Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution.

Key Points: 
  • Review of multiple clinical trials provided a comprehensive analysis showing that oxybate improves sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy, independent of once- or twice-nightly dosing
    DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that six abstracts presenting data from across its sleep medicine portfolio were featured at the 36th annual Psych Congress, held September 6-10, 2023.
  • One of the accepted abstracts provided a comprehensive review of clinical data that assessed the impact of oxybate on sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy.
  • The review found that oxybate improved measures of sleep architecture and disrupted nighttime sleep in narcolepsy patients, independent of dosing regimen or prior oxybate experience.
  • "Idiopathic hypersomnia has a profound impact on those who live with this debilitating sleep disorder," said Kelvin Tan, MBBCh, MRCPCH, senior vice president and chief medical officer of Jazz Pharmaceuticals.

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

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木曜日, 9月 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.

HARMONY BIOSCIENCES REITERATES CONFIDENCE IN WAKIX® (PITOLISANT) PATENTS FOLLOWING FAVORABLE DECISION BY U.S. PATENT AND TRADEMARK OFFICE (USPTO) TO DENY PETITION FOR REEXAMINATION  

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月曜日, 8月 28, 2023
Harmony, Patent, Narcolepsy, Patient, Idiopathic hypersomnia, DSM-IV codes, Pharmaceutical industry

PLYMOUTH MEETING, Pa., Aug. 28, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today commented on the favorable decision by the U.S. Patent and Trademark Office (USPTO) to deny a Petition for Reexamination concerning a patent covering the active ingredient in WAKIX® (pitolisant).

Key Points: 
  • PLYMOUTH MEETING, Pa., Aug. 28, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today commented on the favorable decision by the U.S. Patent and Trademark Office (USPTO) to deny a Petition for Reexamination concerning a patent covering the active ingredient in WAKIX® (pitolisant).
  • The Company issued the following statement:
    We are pleased that the U.S. Patent and Trademark Office (USPTO) rejected a challenge to the validity of claims within the patent covering the active ingredient in WAKIX® (pitolisant), in line with our expectations.
  • This decision not only underscores our confidence in the strength of the WAKIX patent portfolio but also reinforces our belief in the potential of the WAKIX franchise.
  • We are proud of the work we do every day to address the unmet medical needs of patients living with rare neurological diseases.

Zevra Therapeutics Reports Corporate Updates and Second Quarter 2023 Financial Results

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月曜日, 8月 14, 2023
Exercise, Drug development, Priority review, Conference call, Food, New Drug Application, NDA, Business, Narcolepsy, G&A, Research, Sale, Zebra, Acquisition, Investment, Niemann–Pick disease, Patient, Data, Corporation, Webcast, SDX, NPC, R, FDA, Therapy, Sleep, Regulation of tobacco by the U.S. Food and Drug Administration, IND, Idiopathic hypersomnia, Conference, Disease, Real estate, Broadcasting, Pharmaceutical industry, Cryptocurrency, IH

CELEBRATION, Fla., Aug. 14, 2023 (GLOBE NEWSWIRE) --  Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the quarter ended June 30, 2023. 

Key Points: 
  • ET
    CELEBRATION, Fla., Aug. 14, 2023 (GLOBE NEWSWIRE) --  Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the quarter ended June 30, 2023.
  • AZSTARYS milestone revenues, ongoing royalties from AZSTARYS, and the French early access program for arimoclomol primarily drove Q2 2023 net revenue.
  • General and administrative (G&A) expenses were $7.0 million for Q2 2023, compared to $3.6 million in Q2 2022.
  • ET, to discuss its corporate and financial results for Q2 2023.