Associated tags: Brain, Disease, Wakefulness, Patient, Sleep paralysis, Hallucination, EDS, REM, Woman, Pharmaceutical industry, Narcolepsy, Research, Idiopathic hypersomnia, FDA, IH, Sleep, Therapy, Food, Conference, DSM-IV codes, MD
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Pharmaceutical industry AXS-12 also reduced excessive daytime sleepiness (EDS) severity, improved cognitive function, and reduced overall narcolepsy severity as compared to placebo.
Key Points:
- AXS-12 also reduced excessive daytime sleepiness (EDS) severity, improved cognitive function, and reduced overall narcolepsy severity as compared to placebo.
- SYMPHONY was a Phase 3 multicenter, randomized, double-blind, placebo-controlled trial in which 90 patients with a diagnosis of narcolepsy with cataplexy were randomized to treatment with AXS-12 or placebo for 5 weeks.
- “The SYMPHONY Phase 3 trial results confirm the promise and potential of AXS-12 for the treatment of narcolepsy,” said Dr. Herriot Tabuteau, CEO of Axsome Therapeutics.
- Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss the topline SYMPHONY study results in narcolepsy.
Diagnosis,
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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.
Retrieved on:
Thursday, February 22, 2024
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Bank statement Net product revenue for the quarter ended December 31, 2023 was $168.4 million, compared to $128.3 million for the same period in 2022.
Key Points:
- Net product revenue for the quarter ended December 31, 2023 was $168.4 million, compared to $128.3 million for the same period in 2022.
- The average number of patients on WAKIX increased by approximately 350 sequentially to approximately 6,150 for the quarter ended December 31, 2023.
- Total Operating Expenses in the fourth quarter of 2023 included one-time Zynerba transaction related costs of $9.8 million.
- ET
We are hosting our fourth quarter and full year 2023 financial results conference call and webcast today at 8:30 a.m. Eastern Time.
Retrieved on:
Tuesday, November 7, 2023
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Vipul Ved Prakash,
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Emilie Christaller,
Acquisition,
Idiopathic hypersomnia,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
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Zebra,
Acer Ended Q3 2023 with $83.4M in cash, cash equivalents, and investments, supporting our forecasted cash runway into 2026
Key Points:
- Ended Q3 2023 with $83.4M in cash, cash equivalents, and investments, supporting our forecasted cash runway into 2026
Conference call and live audio webcast scheduled for today,
CELEBRATION, Fla., Nov. 07, 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 September 30, 2023.
- Overview of Q3 2023 Financial Results:
Net revenue for Q3 2023 was $2.9 million compared to prior year Q3 net revenue of $2.9 million.
- As of September 30, 2023, these assets are included in secured corporate notes in the unaudited condensed consolidated balance sheet and totaled $42.0 million as of September 30, 2023.
- ET, to discuss its corporate and financial results for Q3 2023.
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Tuesday, October 31, 2023
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Harmony Key Points:
- ET
PLYMOUTH MEETING, Pa., Oct. 31, 2023 (GLOBE NEWSWIRE) -- 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 reported financial results and business updates for the quarter ended September 30, 2023.
- The average number of patients on WAKIX increased by approximately 350 sequentially to approximately 5,800 for the quarter ended September 30, 2023.
- Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release.
- ET
We are hosting our third quarter 2023 financial results conference call and webcast today, beginning at 8:30 a.m. Eastern Time.
MB,
Jazz Pharmaceuticals,
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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.
Retrieved on:
Wednesday, October 18, 2023
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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.
Retrieved on:
Sunday, September 10, 2023
Psych,
Idiopathic hypersomnia,
Doctor of Philosophy,
Safety,
API,
IH,
Drug,
Research,
Zebra,
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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
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Monday, September 11, 2023
Psych,
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Abstract (summary),
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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.
Retrieved on:
Monday, September 11, 2023
Psych,
Abstract,
Abstract (summary),
Bachelor of Medicine, Bachelor of Surgery,
Narcolepsy,
Depression,
University,
Idiopathic hypersomnia,
Magnesium,
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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.
