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Mittwoch, 10.04.2024 07:45 von

Jazz Pharmaceuticals to Showcase Expansive Neuroscience Portfolio at American Academy of Neurology Annual Meeting

Pipette und Proben (Symbolbild). © alvarez / E+ / Getty Images http://www.gettyimages.de

PR Newswire

Two oral presentations share results of real-world impact of idiopathic hypersomnia and long-term effectiveness of Epidiolex® (cannabidiol) in treatment-resistant epilepsies

Thirteen abstracts underscore Jazz's diverse neuroscience portfolio and pioneering efforts to continue advancing the treatment of serious sleep disorders, rare epilepsy syndromes and movement disorders

DUBLIN, April 10, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that 13 abstracts from across its neuroscience portfolio and pipeline, including two oral presentations, will be featured at the 76th Annual American Academy of Neurology Meeting (AAN) being held April 13-18, 2024, in Denver.

Two encore datasets were selected for oral presentations, including results from a real-world claims analysis that demonstrated the increased risk of comorbid conditions, such as stroke or cardiovascular disease, in individuals living with idiopathic hypersomnia compared to those without the condition. Additional data being presented include a post-hoc analysis from the Epidiolex® (cannabidiol) oral solution Expanded Access Program (EAP) that explores the long-term effectiveness of Epidiolex on reduction of treatment-resistant focal-onset seizures.

"Jazz's presentations at the 2024 AAN Annual Meeting reflect our leadership in sleep and rare epilepsies, as well as our commitment to developing therapies for debilitating, and often overlooked, neurological disorders," said Rob Iannone, MD, MSCE, executive vice president and global head of research and development of Jazz Pharmaceuticals. "We remain committed to expanding our knowledge of the patient experience, including the real-world impact and effectiveness of our products, in order to achieve our purpose of transforming the lives of patients and their families."

Highlights at the 2024 AAN Annual Meeting include:

  • An oral presentation showcasing results from the Real-World Idiopathic Hypersomnia Total Health Model (RHYTHM) study which, using claims data, compared the comorbid conditions of individuals diagnosed with idiopathic hypersomnia with those experienced by individuals without idiopathic hypersomnia. Results revealed that individuals with idiopathic hypersomnia experienced higher odds of comorbid conditions across multiple clinical categories, including cardiovascular conditions, reaffirming the importance of considering the patient's full clinical profile when evaluating treatment options for patients living with idiopathic hypersomnia.
  • A second oral presentation focusing on a post-hoc analysis that examined the real-world outcomes and long-term effectiveness of Epidiolex in treatment-resistant focal-onset seizures in individuals who participated in the EAP. Findings showed that Epidiolex was associated with a reduction in focal seizures through 144 weeks, with an acceptable safety profile.
  • Two posters assessing the impact of Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution, the first and only low-sodium oxybate, on sleep inertia in individuals living with idiopathic hypersomnia, including results from a Phase 3 trial.
  • One poster reporting the final results from the SEGUE study of adults with narcolepsy transitioning from Xyrem® (sodium oxybate) oral solution, a high-sodium oxybate, to Xywav, showing that participants switched from high-sodium to low-sodium oxybate with minimal adjustments to their dosing.
  • A poster reviewing key data from five clinical studies evaluating the impact of all once- and twice-nightly high-sodium oxybates on sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy. The review found that oxybate was effective in improving measures of sleep architecture and disrupted nighttime sleep in patients with narcolepsy. Xyrem is indicated for the treatment of cataplexy and/or excessive daytime sleepiness (EDS) in narcolepsy patients.
  • Five posters examining real-world treatment patterns, effectiveness and caregiver experiences with Epidiolex. Notable presentations include updated interim results of seizure and non-seizure outcomes from the cross-sectional BEhavior, COgnition, and More with Epidiolex (BECOME) tuberous sclerosis complex (TSC) caregiver survey, where the majority of caregivers reported improvements in patient seizure and non-seizure outcomes, including cognition, emotional and communication domains. Additionally, a post-hoc analysis demonstrated long term effectiveness of Epidiolex across all focal seizure subtypes in patients with TSC in GWPCARE6 Open Label Extension trial.
  • Two posters featuring Jazz's research with investigational suvecaltamide (also known as JZP385) in essential tremor (ET) and Parkinson's disease (PD) tremor. Presentations include insights from a systematic review of existing literature on the epidemiology and treatment patterns of patients with ET, emphasizing the need for additional research in the space, and a study design overview of the ongoing Phase 2, proof-of-concept study evaluating the efficacy and safety of suvecaltamide on the functional impact of tremor in PD.

The 2024 AAN Annual Meeting abstracts are available online at https://index.mirasmart.com/AAN2024/.


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A full list of Jazz-sponsored presentations follows:

Presentation Title

Presenting Author

Date / Time (MDT) / Session Title / Presentation Number

Idiopathic Hypersomnia Data

Real-World Idiopathic Hypersomnia Total Health Model (RHYTHM): Clinical Burden of Patients Diagnosed With Idiopathic Hypersomnia

J Black

 

Type: Oral

Session Name: S36: Sleep Neurology Highlights

Code: S36.009

Session Date/Time:

Wednesday, April 17, 5:06PM

Minimal Clinically Important Difference for the Visual Analog Scale for Sleep Inertia Using Data From a Phase 3 Trial of Low-Sodium Oxybate for Idiopathic Hypersomnia

L Schneider

Type: Poster

Session Name: P10: Sleep 3

Code: P10.005

Session Date/Time:

Wednesday, April 17,

11:45AM – 12:45PM

Efficacy of Low-Sodium Oxybate by Baseline Sleep Inertia in a Phase 3 Clinical Study in Participants with Idiopathic Hypersomnia

M Whalen

Type: Poster

Session Name: P10: Sleep 3

Code: P10.003

Session Date/Time:

Wednesday, April 17,

11:45AM – 12:45PM

Narcolepsy Data

Effectiveness and Optimization of Low-Sodium Oxybate in Participants with Narcolepsy Switching From Sodium Oxybate: Final Data From the Substitution of Equal Grams of Uninterrupted Xyrem to Xywav (SEGUE) Study

D Fuller

Type: Poster

Session Name: P10: Sleep 3

Code: P10.001

Session Date/Time:

Wednesday, April 17,

11:45AM – 12:45PM

Effects of Oxybate on Sleep, Sleep Architecture, and Disrupted Nighttime Sleep

J Black

Type: Poster

Session Name: P10: Sleep 3

Code: P10.006

Session Date/Time:

Wednesday, April 17,

11:45AM – 12:45PM

Epilepsy Data

Long-term Effectiveness of Cannabidiol (CBD) Against Focal-Onset Seizures in Treatment-Resistant Epilepsies (TRE): Experience from the Expanded Access Program (EAP)

YD Park

Type: Oral

Session Name: S29: Epilepsy Diagnostics and Therapeutic

Code: S29.005

Session Date/Time:

Wednesday, April 17, 1:48PM

Real-World Treatment Patterns of Patients with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) in the United States (U.S.)

SV Kothare

Type: Poster

Session Name: P1: Epilepsy / Clinical Neurophysiology (EEG): Pediatric Epilepsy 1

Code: P1.005

Session Date/Time:

Sunday, April 14,

8:00AM – 9:00AM

Real-world Safety and Effectiveness of Cannabidiol (CBD) in Adults with Treatment-Resistant Epilepsies (TREs): Long-term Results From the United States Expanded Access Program (EAP)

JP Szaflarski

Type: Poster

Session Name: P8: Epilepsy / Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials and Outcomes

Code: P8.002

Session Date/Time:

Tuesday, April 16,

5:30PM – 6:30PM

Caregiver-Reported Seizure Outcomes with Real-World Use of Cannabidiol (CBD) in Tuberous Sclerosis Complex (TSC): Interim Results from the BECOME-TSC Survey

MK Koenig

Type: Poster

Session Name: P8: Epilepsy / Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials and Outcomes

Code: P8.005

Session Date/Time:

Tuesday, April 16,

5:30PM 6:30PM

Caregiver-Reported Nonseizure Outcomes with Real-World Use of Cannabidiol (CBD) in Tuberous Sclerosis Complex (TSC): Interim Results From the BECOME-TSC Survey

S Wilson

Type: Poster

Session Name: P8: Epilepsy / Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials and Outcomes

Code: P8.010

Session Date/Time:

Tuesday, April 16,

5:30PM 6:30PM

Long-Term Effectiveness of Cannabidiol (CBD) Against Focal Seizures in Tuberous Sclerosis Complex (TSC): Results From the GWPCARE6 Open-Label Extension (OLE) Trial

 

JY Wu

 

Type: Poster

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